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TE-CERT211100038-01 STC User manual 1 | Users Manual | 1.40 MiB | December 20 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-01 STC User manual 2 | Users Manual | 183.86 KiB | December 20 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-01 STC Internal photos | Internal Photos | 1.18 MiB | December 20 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-01 STC External photos | External Photos | 497.44 KiB | December 20 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-02 Label & Label Location 1217 | ID Label/Location Info | 86.78 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 Form Applicant Declaration Letter Rev0 | Cover Letter(s) | 212.76 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 Form SGS FCC Confidentiality Request Letter | Cover Letter(s) | 221.50 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 Form SGS FCC agent auth letter | Cover Letter(s) | 206.00 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 STC Test setup photos for 13.56MHz NFC | Test Setup Photos | 847.45 KiB | December 20 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-01 TR E2-2021-80083 P15.225+RSS 210 13.56MHz NFC | Test Report | 1.34 MiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-02 E2-2021-80084 FCC+IC 20cm 1217 | RF Exposure Info | 323.85 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 Form WIFI ch 12 -13 Declaration letter | Cover Letter(s) | 182.49 KiB | December 20 2021 / December 23 2021 | |||
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TE-CERT211100038-01 STC Test setup photos for WLAN | Test Setup Photos | 1.07 MiB | December 19 2021 / June 22 2022 | delayed release | ||
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TE-CERT211100038-01 TR E2-2021-80082 P15.247+RSS-247 WLAN | Test Report | 4.23 MiB | December 20 2021 / December 23 2021 |
1 2 | TE-CERT211100038-01 STC User manual 1 | Users Manual | 1.40 MiB | December 20 2021 / June 22 2022 | delayed release |
LooK SPOT 2 COVID-19 Test System Instruction of Use For LooK SPOT 2 For in vitro Use Only For use with nasal swab specimens INTENDED USE LooK SPOT 2 COVID-19 Test System is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in nasal swabs from patients suspected of COVID-19 within the first eight
(8) days of symptom onset. LooK SPOT 2 COVID-19 Test System is intended for use by trained professionals. For laboratory and point of care use. This assay is not intended for home testing. Results are for the identification of SARS-CoV-2 nucleocapsid protein. This antigen is generally detectable in the nasal sample during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of the disease. Laboratories are required to report all positive results to the appropriate public health authority. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The LooK SPOT 2 COVID-19 Test System does not differentiate between SARS-CoV and SARS-CoV- 2. LooK SPOT 2 COVID-19 Test System can detect the SARS-CoV-2 virus and its variants between 5 to 8 minutes with normal mode and within 15 seconds using SPEED mode. LooK SPOT AI cloud can identify the color response when human eyes cannot identify the low positive cases. Healthcare responders in the COVID-19 test sites often need to make time-sensitive decisions to determine the test results during the time many patients are within their vicinity. But the tempo, volume, stress, fatigue, lighting, fear, and various other factors can overwhelm healthcare responders when making the visual interpretation of antigen test results. It is of paramount importance to reduce healthcare responders' cognitive load by providing accurate test results in an easy-to-read format. LooK SPOT 2 COVID-19 Test System is intended for use at the Point of Care (POC) settings by medical and trained professional in vitro diagnostic procedures. 1 | P a g e SUMMARY The SARS-CoV-2 virus is a positive-stranded single-stranded RNA virus with an envelope with a virus particle diameter of about 50200nm; it is composed of four main structural proteins: spike protein (S), an envelope protein (E), membrane protein (M) and nucleocapsid protein (N). The nucleocapsid protein binds to the viral RNA, and the other three proteins together form the viral coat. Its gene sequence is similar to SARS and MERS viruses, but they belong to different species. The incubation period of the SARS-CoV-2 is about 2-14 days on average; most patients will have respiratory symptoms. Typical symptoms include frequent fever, dry cough, weakness of limbs, etc. (may be accompanied by muscle pain, diarrhea, sore throat, loss of smell and abdominal pain, etc.). There is a percentage of carriers without any clinical symptoms. Severe patients may develop acute respiratory distress syndrome (ARDS), septic shock, diffuse alveolar injury, or even death. LooK SPOT 2 COVID-19 Test System is an immunochromatographic test that uses monoclonal antibodies combined with latex particles to detect whether there are SARS-CoV-2 antigens in nasal secretions. This test is easy to execute, and the test result can be ready between five (5) to eight (8) minutes using the LooK SPOT 2. The patients can also download a free LooK PASS app for the Android and iOS systems to receive the test result in real-time. LooK PASS will generate a test certificate with detailed information about the test. TEST PRINCIPLE LooK SPOT 2 COVID-19 Test System uses a rapid immunochromatographic detection method to detect whether the nucleocapsid protein of the SARS-CoV-2 virus is present in the nasal swab samples using specific monoclonal antibodies. LooK COVID-19 antigen rapid test reagent is designed to detect whether patients who are suspected of being infected by the SARS-CoV-2 virus have the SARS-CoV-2 antigen in the nasal swabs. Before performing the test, the patient can download and register the LooK PASS app from Google Play Store or Apple App Store. The patient scans the QR code of the LooK COVID-19 antigen cassette with the LooK PASS app, and the information is uploaded to the LooK SPOT AI Cloud for the registration of the test. Each LooK COVID-19 antigen rapid test cassette has an embedded microchip for security, quality control, and identification purposes. This will guarantee the patient can receive the test result on their phone in real-time with full privacy. LooK PASS app 2 | P a g e To perform the test, a nasal swab specimen is collected from the patient. Place the nasal swab into the Extraction Buffer tube. Stir the nasal swab in the Extraction Buffer tube for one (1) minute. The virus particles in the sample are disrupted and exposing the internal viral nucleoproteins. After disruption, use the dropper to extract the solution inside the tube and apply three drops in the sample window of the LooK COVID-19 antigen cassette. The sample migrates through the antigen cassette containing unique chemical environments. If SARS-CoV-2 viral antigen is present, they will be trapped in a specific location on the test window of the antigen cassette. Insert the LooK COVID-19 antigen cassette into one of the slots of LooK SPOT 2. LooK SPOT 2 sends the images of the color signal of the cassette's test window to LooK SPOT AI Cloud for analysis. LooK SPOT AI Cloud analyzes the images using proprietary AI algorithms and sends the test results to the LooK SPOT 2. The test result can be Positive, Negative, or Invalid. The test result is also sent to the patient's LooK PASS app to generate a test certificate. MATERIALS SUPPLIED FOR LOOK SPOT 2 1. LooK SPOT 2 (1) 2. AC/DC Power Adaptor (1) 3. Cable for Power Adaptor (1) 4. Package Insert (1): Instruction of use MATERIALS REQUIRED BUT NOT SUPPLIED 1. LooK COVID-19 Antigen Cassettes (10) 2. Droppers (10) 3. Extraction Buffer (10) 4. Nasal swabs (10): Puritan 5. Package Insert (1): Instruction of Use 6. Android Smartphone with OS 7.1 and above, iPhone 6 and above, with iOS 13+, must have a rear camera of 8 megapixels or above. See the List of Tested and Supported Smartphones in LIMITATIONS 13. 7. AAA Battery x 2 8. Personal Protective Equipment (PPE) WARNINGS AND PRECAUTIONS 1. For in vitro diagnostic use. 2. Do not use the product contents beyond the expiration date printed on the outside of the box. 3. This reagent is only authorized to detect the nucleocapsid protein antigen of the SARS-CoV-2 virus and is not authorized to detect any other viruses or pathogens. 4. Use precautions in the collection, handling, and disposal of patient samples. 5. Use proper personal protective equipment (PPE) for the handling of patient samples. 6. The Extraction Buffer tube contains a saline solution and sodium azide, which is harmful if inhaled, swallowed, or in contact with the skin. Contact with acidic substances may produce highly toxic gas. If you accidentally touch your skin, please rinse immediately with plenty of water. Sodium azide may react with lead or copper pipes to form explosive compounds. Therefore, it is recommended to rinse with plenty of water to avoid the accumulation of azide. 7. When collecting nasal specimens, please use the nasal swab provided by LooK COVID-19 Antigen Rapid Test kit. Do not use other swabs, which may result in false-negative results. 8. Never open the sealed aluminum foil bag of the cassette, exposing it to the ambient temperature and 3 | P a g e humidity too early before the moment for immediate use. 9. Discard any suspected used or damaged cassette. 10. When the antigen in the sample is lower than the detection limit of the product, incorrect sample collection or transportation will lead to false-negative results. Therefore, a negative result cannot rule out the possibility of SARS-CoV-2 infection due to the mishandling of the sample collection process. 11. Do not pour the solution from the Extraction Buffer tube into the sample window of the cassette. Use the dropper provided inside the sealed aluminum foil bag of the cassette. 12. Do not write on the barcode of the cassette or peel off the barcode sticker. 13. Testing should be performed in an indoor area with adequate ventilation. 14. The Instruction of Use must be followed for a good result. 15. LooK SPOT 2 must be used to obtain good results for LooK COVID-19 Antigen Rapid Test. 16. Use the LooK COVID-19 Antigen Rapid Test with LooK SPOT 2 on a flat surface so the antigen cassette will not move out of focus from the camera. 17. Dispose of unused contents in accordance with Federal, State, Province, and Local regulatory requirements. 18. Wash hands thoroughly after completing the test. 19. If you have no previous experience collecting samples and handling the test reagents, please seek training or refer to relevant operating instructions. A training video can be found on www.laipac.com. 20. For additional information on the hazard symbols, safety, handling, and disposal of the components within this kit, please refer to the Material Safety Data Sheet (MSDS) at www.Laipac.com. Store the kit at room temperature, 59F to 86F (15C to 30C), out of direct sunlight until the expiration date. Do not use the kit after the expiration date. There are three types of Quality Control for using LooK COVID-19 Antigen Rapid Test with LooK SPOT 2:
KIT STORAGE QUALITY CONTROL Built-in Procedural Controls External Quality Controls Built-in Procedural Controls The images of the LooK COVID-19 antigen cassette taken from the LooK SPOT 2 are sent to LooK SPOT AI Cloud for analysis. LooK SPOT AI Cloud has a built-in procedural controls process to detect positive, negative, or invalid test results. Each image is associated with LooK COVID-19 antigen cassette built-in microchip. This microchip is associated with the unique QR code on the back of each LooK COVID-19 antigen cassette. The QR code of the cassette is scanned by the patient using the LooK PASS app before the COVID-19 antigen test. The patient will receive a test certificate once the test is completed. The test certificate contains the following information on the test:
The name of the patient, date of birth, personal ID and picture The test result, type of test, type of sample, sample collection date and time The name of the test name, manufacturer of the test The testing provider name, operator name, test completion date and time 4 | P a g e City, country, test certificate ID and the issuer The Built-in Procedural Controls that involve the microchip and QR code for the LooK SPOT 2 COVID-19 Test System have secured the test process to have privacy and accuracy for correct result-to-patient in a fast pace testing environment. If the test procedure does not flow correctly, LooK SPOT AI Cloud will alert the event to the operator of the LooK SPOT 2 on the display screen. 5 | P a g e The test results are documented automatically in the History section of the LooK SPOT 2 with the Test ID, location, city, country, and timestamp of the tests. If the test did not flow correctly, the test result would show Invalid. The additional Built-in Procedural Controls also display error messages on the LooK SPOT 2 and the LooK PASS app to follow the corrective procedures and mitigate the issues. The following table describes the errors that can occur during the test and the mitigations. ID. Error Notification Cause of Error Solution Measure Fail to sign in for the LooK SPOT 2 and LooK PASS app a. The account does not exist b. Wrong user name or password, forgot the password a. Create a new account b. Choose to reset the password Fail to create a new user account for the LooK SPOT 2 and LooK PASS app a. Email already exists b. Email is invalid c. Mandatory fields not filled a. Reset the password b. Re-type the email address c. Ask the user to fill all required a. Email address does not exist b. Wrong email address a. Verify the email address b. Check the format of the email fields Fail to reset the password for the user account of the LooK SPOT 2 and LooK PASS app LooK SPOT 2 fails to get the antigen test cassette's ID and show an unknown cassette a. Check WiFi connection to LooK SPOT 2 b. Not Laipacs antigen cassette c. LooK SPOT 2 device issue LooK SPOT 2 responds with
"INVALID" test result a. Antigen cassette failed to show the Control line b. AI Cloud technical issue c. Sample applied to the cassette over two hours, the contamination on the cassette appears a. Asymptomatic patients with low viral low above Ct 30 a. No wireless connection b. AI cloud server technical issue LooK SPOT 2 responds with a false negative result LooK SPOT 2 fails to access LooK SPOT AI cloud for diagnosis LooK SPOT 2 does not turn on with the pressing of the power button a. Missing the power source b. Device issue Not receiving test results from AI cloud The operator has aborted the test process 6 | P a g e a. Verify WiFi connection of LooK SPOT 2 b. Use a original antigen cassette c. Contact Laipac Support a. Check to see if the test cassette is showing the control line c. Contact Laipac Tech Support d. Discard the antigen cassette with biosafety and use a new antigen cassette with a new sample a. Verify the test result with RT-
PCR test a. Check WiFi network connection c. Contact Laipac Tech support a. Check the AC/DC adaptor and cable connection b. Contact Laipac Support Check with the operator of LooK SPOT 2, and the history will show the information of the test 1 2 3 4 5 6 7 8 9 External Quality Controls This process is using Positive and Negative controls to ensure the test reagents and assay perform correctly. Laipac recommends that Positive and Negative External Quality Controls be used once for each untrained operator, once for each shipment received, and as necessary by your internal quality control procedures, and following Local, State, Provincial, and Federal regulations requirements and accrediting groups. External Positive and Negative control swabs are included in the shipment and should be tested using the swab test procedure provided in the Instruction of Use. If the correct control results are not obtained, do not perform patient tests. Contact Laipac Technology, Inc. Customer Service for assistance Monday through Friday from 9:00 a.m. to 6:00 p.m. Eastern Time at 905-604-3759; info@laipac.com or your local distributor. Additional External Control Swabs may be obtained separately. SAMPLE COLLECTION AND HANDLING SAMPLE COLLECTION The correct sampling method, storage, and transportation have a critical influence on this reagent. The test should be carried out immediately after sampling. In addition, the quality of the sample has a significant impact on product efficiency, and it is recommended to train the sample collection process. For the best test results, please use the nasal swabs in the kit to collect the nasal sample. It has the highest amount of virus in the early stage of symptoms. If the test is taken eight (8) days after the onset of symptoms, it can lead to a false-negative result. In addition, incorrect sample collection, improper sample handling, or transportation errors may all produce false-
negative results. TEST PROCEDURES Nasal Swab Sample Collection For the best test results, use the nasal swabs provided in the LooK COVID-19 Antigen Rapid Test kit to collect the nasal sample. During the collection process, to obtain as much secretion as possible, the nasal swab must be inserted into the nostril where there are more secretion and visible drainage, or the most congested nostril if drainage is not visible. Push the swab until stopping at the level of the turbinate (one inch into the nostril). Rotate the swab five (5) times or more against the nasal wall, then slowly remove it from the nostril. Repeat the same process in the other nostril with the same swab. 7 | P a g e The freshly collected sample should be processed as soon as possible, and it is recommended to complete the test within 1 hour after sampling. All clinical samples must be at room temperature before the test. Check the expiration date on each LooK COVID-19 antigen cassette package or outer box, DO NOT use any antigen cassette or nasal swabs past the expiration date on the label. Nasal Swab Test Procedure 1. Place the patient nasal swab sample into the Extraction Buffer Tube. Roll the swab at least five (5) times while pressing the head against the bottom and side of the tube. 2. Leave the swab in the Extraction Buffer Tube for 1 minute. Roll the swab head against the inside of the tube as removing it. Dispose of the used swab in biohazard waste. 3. Fill the disposable dropper with the patient sample from the Extraction Buffer Tube:
a. Squeeze the bulb. b. Still squeezing, place the dropper tip into the patient sample. c. Slowly release the pressure on the bulb to fill the dropper 4. Dispense three (3) drops of sample to the round sample window above the arrow mark on the cassette. Do not touch the cassette with the tip of the dropper. NOTE: Do not pour the sample from the Extraction Buffer Tube directly to the cassette 8 | P a g e 1. The first step is to connect the LooK SPOT 2 with an AC 110/220V electrical socket using the AC/DC adaptor. Wait for the initialization, and the main screen will appear. LooK SPOT 2 uses a touch screen display. Select the WiFi hotspot to connect to the internet. Internet connection with WiFi is fundamental for this test. Using LooK SPOT 2 2. Click the Profile icon to sign in with the users email address and password. 9 | P a g e 3. For new users, select Create an account and enter your basic info. You shall receive an email to confirm the email address and validate your account with LooK SPOT AI cloud. 4. If you forget the password, please choose to reset the password, and you shall receive an email with a temporary password for the access. 5. After login, enter the info of the place, city, country and the testing provider site. These are mandatory info to start the test. Press Continue, the main test screen shows up with the default setting of Auto Mode and NORMAL mode. AUTO MODE means the test will detect the LooK COVID-19 antigen rapid test cassette with a built-in microchip. NORMAL mode is the regular test procedure that will take between 5 to 8 minutes per test. SPEED mode is a fast test procedure that will take between 10 to 20 seconds. To conduct a SPEED mode test, ensure the LooK COVID-19 antigen rapid test cassette has the nasal sample on for at least 8 minutes before inserting it to LooK SPOT 2. Switching the test mode by touching the screen. 10 | P a g e 6. Now insert the LooK COVID-19 antigen test cassette into a slot, and the detection will start automatically. 7. Under Normal mode, the test result shall appear between 5-8 minutes showing Negative (white), Positive
(red) or Invalid (yellow). 8. Remove the test cassette and dispose of it in biohazard waste. The LooK SPOT 2 will sterilize automatically with an internal UV light for 5-10 seconds. 11 | P a g e CLINICAL PERFORMANCE The LooK SPOT 2 COVID-19 Test System clinical performance was evaluated with patient specimens collected in multiple sites in Ontario Canada. In this study, 95 patients with suspected COVID-19 have participated. Patients who presented within eight (8) days of symptom onset were included in the study. There were eleven (11) asymptomatic patients, and one (1) of them was tested positive for SARS-CoV-2. A Real-Time Polymerase Chain Reaction (RT-PCR) assay was utilized as the comparator method for this study. The BioMerieux MucliSENS extraction system was used to extract total nucleic acid. Extracted nucleic acid was then amplified in three separate reactions using the CDC N1, N2, and RNase P primer set using the Promega GoTaq kit on a BioRAD C.F.X. Real-time PCR system. The collected specimens were transported in Universal Transport Medium (UTM), and all sites shipped the UTM samples to the lab center for this clinical performance study. The samples were run as per test protocol, where the swab was mixed in the extraction buffer (450uL) and left in for one minute. Then apply three drops (45-60uL) of the buffer mix onto the LooK COVID-19 Antigen Cassette to start the test with LooK SPOT. LooK SPOT 2 COVID-19 Test System Performance within eight (8) days of symptom onset:
LooK SPOT 2 COVID-19 Test Systemt Positive Negative Total Comparator Method Positive 37 1 38 Negative 1 56 57 Positive Agreement: 37/38 97.4% (95% CI: 86.2% 99.9%) Negative Agreement: 56/57 98.3% (95% CI: 90.6% 100%) Total 38 57 95 Patient demographics (gender, age, asymptomatic, number of days since the onset of symptoms) are available for the 95 samples used in the analysis. The following table shows the results vs. age of the patient:
Age
< 5 years 6 to 21 years 22 to 59 years
> 60 years LooK SPOT 2 COVID-19 Test System Total #
4 3 51 37 Positive 2 1 20 14 Prevalence 50.0%
33.3%
39.2%
37.8%
12 | P a g e Symptoms present [% Yes, (n/N)]
Days from symptom onset [median(Q1-Q3); N]
3 (-2.5); 40 Days < 0-3 (n, %) Gender [%F, (n/N)]
Description of Study Cohort Positivity [%, (n/N)]
Ct > 25 (n, %) Ct > 30 (n, %) Ct > 33 (n, %) Days 4-7 (n, %) Days > 8 (n, %) PCR Ct [median (Q1-Q3); N]
49.47% F, (47/95) 47.37% Yes, (45/95) 22 (53.66%) 14 (34.15%) 0 (0%) 40%, (38/95) 0 (-23.02); 190 6, (3.16%) 20, (10.53%) 39, (20.53%) LooK SPOT 2 COVID-19 Test System Clinical Performance Summary Clinical Sensitivity (95% CI), N 97.37% (86.19% to 99.93%), 95 Sensitivity days 7, N Sensitivity Ct 33, N Sensitivity Ct 25, N Clinical Specificity (95% CI), N Invalid Rate (%, n/N) Analytical Sensitivity (Ct, viral gene copies/mL) 97.06% (84.67% to 99.93%), 91 97.06% (84.67% to 99.93%), 91 100.00% (82.35% to 100.00%), 76 98.25% (90.61% to 99.96%), 95 0%, (0/95) 30.93 Ct, 1.29X105 viral gene copies/mL LooK SPOT 2 COVID-19 Test System Test Results vs. Age of Patients Age (yr.) LooK SPOT 2 COVID-19 Test System RT-PCR Total Positive Prevalence Total Positive Prevalence
< 5 6 21 22 -59
> 60 4 3 50 38 2 1 20 15 50.00%
33.30%
40.00%
39.47%
4 3 50 38 2 1 21 14 50.00%
33.30%
42.00%
36.84%
13 | P a g e
37 1 38
33 1 34
19 0 19 Specificity vs Sensitivity for all samples LooKTM SPOT Results
Total RT-PCR Results
Total 1 56 57 38 57 95 LooK SPOT 2 COVID-19 Test System Sensitivity: 97.37%
LooK SPOT 2 COVID-19 Test System Specificity: 98.25%
Specificity vs Sensitivity for samples with Ct 33 LooKTM SPOT Results
Total RT-PCR Results
Total 1 56 57 34 57 91 LooK SPOT 2 COVID-19 Test System Sensitivity: 97.06%
LooK SPOT 2 COVID-19 Test System Specificity: 98.25%
LooK SPOT 2 COVID-19 Test System and RT-PCR for samples with Ct 25 LooK SPOT Results
Total RT-PCR Results
Total 1 56 57 20 56 76 LooK SPOT 2 COVID-19 Test System Sensitivity: 100.00%
LooK SPOT 2 COVID-19 Test System Specificity: 98.25%
14 | P a g e LIMIT OF DETECTION (ANALYTICAL PERFORMANCE) The LOD (Limit of Detection) studies determined the lowest detectable concentration of SARS-CoV-2, at which at least 95% of all (true positive) replicates tested positive. The LoD for the LooK SPOT 2 COVID-19 Test System was 1.2910 TCID /ml based on 20 replicates. This was established by spiking increasingly dilute amounts of heat-
inactivated SARS-CoV-2 (ATCC VR-1986HK) in the nasal extract of a COVID-19 negative donor. ATCC VR-
1986HK is a preparation of Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) strain 2019-
nCoV/USA-WA1/2020 that has been inactivated by heating to 65C for 30 minutes and is therefore unable to replicate. Limit of Detection (LoD) Study Results Concentration 1.2910 TCID /ml Number Positive/Total 19/20
% Detected 95%
HOOK EFFECT No noticeable high dose hook effect was observed when tested with up to a concentration of 3.01x105 TCID
/Sample (70 ul), or 4.30 x 106 TCID /ml heat-inactivated SARS-CoV-2 virus using LooK SPOT 2 COVID-19 Test System. CROSS-REACTIVITY The LooK SPOT 2 COVID-19 Test System has no cross-reactivity with microorganisms (Virus, Bacteria) and other materials listed in the following table except for Autoimmune disease (Rheumatoid factor) plasma. Virus, Bacteria and Fungi Concentration Cross-Reactivity Coronavirus (Strain: 229E) Culture Fluid, Coronavirus (Strain: OC43) Culture Fluid Coronavirus (Strain: NL63) Culture Fluid, MERS-CoV (Strain: Florida/USA-2_Saudi Arabia_2014) Culture Fluid NATtrol Coronavirus-SARS Stock Adenovirus Type 1 Culture Fluid Human Metapneumovirus (hMPV) 9 Type A1 Culture Fluid, IA3-2002 Human Metapneumovirus (hMPV) 5 Type B1 Culture Fluid, Peru3-2003 Parainfluenza Virus Type 1 Culture Fluid 6.3 x 105 TCID50/ml 2.5 x 105 TCID50/ml 8.5 x 104 TCID50/ml 2.1 x 105 TCID50/ml Nucleic Acid Detection by PCR; Amount not specified 3.80 x 106 TCID50/ml 8.5 x 104 TCID50/ml 5 x 105 U/ml 6.3 x 105 TCID50/ml Negative Negative Negative Negative Negative Negative Negative Negative Negative 15 | P a g e Parainfluenza Virus Type 2 Culture Fluid Parainfluenza Virus Type 3 Culture Fluid Parainfluenza Virus Type 4A Culture Fluid Influenza A H1N1 (New Cal/20/99) Culture Fluid Influenza B (Florida/02/06) Culture Fluid Respiratory Syncytial Virus Type A (RSV-A) Culture Fluid Respiratory Syncytial Virus Type B (RSV-B) Culture Fluid, CH93-18(18) Enterovirus Type 68 Culture Fluid Rhinovirus Type 1A Culture Fluid Haemophilus influenzae type b; Eagan Steptococcus pneumoniae Streptococcus pyogenes Z018, Serotype M58 Candida albicans Pooled human Nasal wash, representative of normal microbial flora Bordetella pertussis A639 Mycoplasma pneumoniae M129 Clamydia pneumoniae, CWL-029 Legionella longbeachae Long Beach 4 Staphylococcus epidermidis MRSE; RP62A Staphylococcus aureus Staphylococcus epidermidis NATSARS(COV2)-NEG. Whole Blood. Mucin, recombinant human Mucin, Bovine submaxillary gland, Vicks VapoCOOL Sore throat
(Menthol/Benzocaine) Naso GEL (NeilMed) CVS Nasal Drops (Phenylephrine) 7.6 x 105 TCID50/ml 1.7 x 107 TCID50/ml 7.05 x 104TCID50/ml 2.04 x 105 TCID50/ml 2.34 x 104 TCID50/ml 1.5 x 106 TCID50/ml 7.71 x 103 TCID50/ml 2.51 x 105 TCID50/ml 7.05 x 104 TCID50/ml 2.81 x 108 CFU/ml 5 x 1010 cells/ml 2.39 x 109 CFU/ml 5 x 109 cells/ml 1X 1.68 x 109 CFU/ml 1.35 x 108 CCU/ml 12.35 Ct 7.5 x 107 CFU/ml 1.24 x 109 CFU/ml 5 x 1010 cells/ml 5 x 1010 cells/ml 5.01 x 104 Cells/ml 4%
0.50%
0.50%
1.5 mg/mL 5% v/v 15% v/v 16 | P a g e Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Endogenous and Exogenous Substances Concentration Cross-Reactivity Afrin (Oxymetazoline) NasalCrom (5.2mg Cromolyn sodium/spray at RiteAid Zicam Cold Remedy (Galphimia glauca 4x, Luffa operculata 4x, Sabalilla 4x) Homeopathic (Alkalol)ALKALOL Mucus Solvent & Cleaner, 16 FL OZ, made by THE ALKALOL Company, Boston Chloraseptic SORE THROAT (1.4% Phenol, Methanol) Tobramycin Mupirocin Mupirocin Fluticasone Propionate Aller-Flo by Kirkland, 50mcg Fluticasone Propionate
(glucocorticoid) Tamiflu (Oseltamivir Phosphate) Autoimmune disease (Human Anti-mouse Antibody (HAMA) Autoimmune disease (Rheumatoid factor ) Serum protein (Whole Blood (human), EDTA anticoagulated, Human serum albumin) 15% v/v 15% v/v 5% v/v 1:10 dilution 15% v/v 40 g/mL 1 mg/mL 10 mg/mL 5% v/v 5 mg/mL 50%
50%
4% as whole blood Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Positive Negative INTERFERENCE The LooK SPOT 2 COVID-19 Test System showed no interference with the potentially interfering substances at the designated concentrations in negative and contrived positive pooled nasal samples. Virus, Bacteria and Fungi Concentration Interference Result in Positive Contrived Samples Interference Result in Negative Samples Coronavirus (Strain: 229E) Culture Fluid, Coronavirus (Strain: OC43) Culture Fluid Coronavirus (Strain: NL63) Culture Fluid, MERS-CoV (Strain: Florida/USA-
2_Saudi Arabia_2014) Culture Fluid 6.3 x 105 TCID50/ml Negative (3X) Negative (3X) 2.5 x 105 TCID50/ml Negative (3X) Negative (3X) 8.5 x 104 TCID50/ml Negative (3X) Negative (3X) 2.1 x 105 TCID50/ml Negative (3X) Negative (3X) 17 | P a g e NATtrol Coronavirus-SARS Stock Nucleic Acid Detection Negative (3X) Negative (3X) Adenovirus Type 1 Culture Fluid Human Metapneumovirus
(hMPV) 9 Type A1 Culture Fluid, IA3-2002 Human Metapneumovirus
(hMPV) 5 Type B1 Culture Fluid, Peru3-2003 Parainfluenza Virus Type 1 Culture Fluid Parainfluenza Virus Type 2 Culture Fluid Parainfluenza Virus Type 3 Culture Fluid Parainfluenza Virus Type 4A Culture Fluid Influenza A H1N1 (New Cal/20/99) Culture Fluid Influenza B (Florida/02/06) Culture Fluid Respiratory Syncytial Virus Type A (RSV-A) Culture Fluid Respiratory Syncytial Virus Type B (RSV-B) Culture Fluid, CH93-
18(18) Enterovirus Type 68 Culture Fluid Rhinovirus Type 1A Culture Fluid Haemophilus influenzae type b;
Eagan Steptococcus pneumoniae Streptococcus pyogenes Z018, Serotype M58 Candida albicans Pooled human Nasal wash, representative of normal microbial flora Bordetella pertussis A639 Mycoplasma pneumoniae M129 Clamydia pneumoniae, CWL-029 by PCR; Amount not specified 3.80 x 106 TCID50/ml 8.5 x 104 TCID50/ml Negative (3X) Negative (3X) Negative (3X) Negative (3X) 5 x 105 U/ml Negative (3X) Negative (3X) 6.3 x 105 TCID50/ml Negative (3X) Negative (3X) 7.6 x 105 TCID50/ml Negative (3X) Negative (3X) 1.7 x 107 TCID50/ml Negative (3X) Negative (3X) 7.05 x 104TCID50/ml Negative (3X) Negative (3X) 2.04 x 105 TCID50/ml Negative (3X) Negative (3X) 2.34 x 104 TCID50/ml Negative (3X) Negative (3X) 1.5 x 106 TCID50/ml Negative (3X) Negative (3X) 7.71 x 103 TCID50/ml Negative (3X) Negative (3X) 2.51 x 105 TCID50/ml Negative (3X) Negative (3X) 7.05 x 104 TCID50/ml 2.81 x 108 CFU/ml 5 x 1010 cells/ml 2.39 x 109 CFU/ml 5 x 109 cells/ml 1X Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) 1.68 x 109 CFU/ml 1.35 x 108 CCU/ml 12.35 Ct Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) 18 | P a g e Endogenous and Exogenous Concentration Interference Result in Positive Contrived Samples Interference Result in Negative Samples Legionella longbeachae Long Beach 4 Staphylococcus epidermidis MRSE; RP62A Staphylococcus aureus Staphylococcus epidermidis NATSARS(COV2)-NEG. Substances Whole Blood. Mucin, recombinant human Mucin, Bovine submaxillary gland, Vicks VapoCOOL Sore throat
(Menthol/Benzocaine) Naso GEL (NeilMed) CVS Nasal Drops
(Phenylephrine) Afrin (Oxymetazoline) NasalCrom (5.2mg Cromolyn sodium/spray at RiteAid Zicam Cold Remedy (Galphimia glauca 4x, Luffa operculata 4x, Sabalilla 4x) Homeopathic (Alkalol)ALKALOL Mucus Solvent & Cleaner, 16 FL OZ, made by THE ALKALOL Company, Boston Chloraseptic SORE THROAT
(1.4% Phenol, Methanol) Tobramycin Mupirocin Mupirocin Fluticasone Propionate Aller-Flo by Kirkland, 50mcg Fluticasone Propionate (glucocorticoid) Tamiflu (Oseltamivir Phosphate) Autoimmune disease (Human Anti-mouse Antibody (HAMA) 7.5 x 107 CFU/ml Negative (3X) Negative (3X) 1.24 x 109 CFU/ml Negative (3X) Negative (3X) 5 x 1010 cells/ml 5 x 1010 cells/ml 5.01 x 104 Cells/ml Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) 4%
0.50%
0.50%
1.5 mg/mL 5% v/v 15% v/v 15% v/v 15% v/v 5% v/v 1:10 dilution 15% v/v 40 g/mL 1 mg/mL 10 mg/mL 10 mg/mL 5% v/v 5 mg/mL Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) Negative (3X) 19 | P a g e Autoimmune disease
(Rheumatoid factor ) Serum protein (Whole Blood
(human), EDTA anticoagulated, Human serum albumin) Whole Blood. LIMITATIONS 50%
50%
Negative (3X) Negative (3X) Negative (3X) Negative (3X) 4% as whole blood Negative (3X) Negative (3X) 1. This product qualitatively detects whether the nasal swab sample has the SARS-CoV-2 virus antigen. 2. Failure to use this product by standard operating procedures may affect product performance and produce invalid results. 3. The sample should be tested as soon as possible after collection. 4. As the number of days of the disease course increases, the number of viral antigens in the sample may decrease. Compared with the molecular diagnosis (RT-PCR) method, the sample after the 8th day of the symptoms may show a false-negative test result. 5. The test results should be comprehensively evaluated with the medical history, epidemiological data, and the patient's clinical symptoms. 6. A positive test result cannot exclude the possibility of co-infection with other pathogens. 7. The negative test result may be because the antigen concentration of the sample is lower than the detection limit of this product or if the sample was collected or transported improperly. 8. A negative test result cannot rule out the possibility of SARS-CoV-2 virus infection; the test result can be confirmed with an authorized molecular diagnosis. 9. When the amino acid on the epitope of the SARS-CoV-2 virus is changed, the monoclonal antibody may 10. The test must be performed with a good internet connection. If the internet connection is not available or not be able to detect or cause low sensitivity not stable, the test result can be invalid. 11. LooK SPOT 2 operation temperature: 0C to 45C, shipping and storage temperature: -25C to 60C 12. LooK SPOT 2 is for multiple uses and can conduct hundreds or thousands of tests. 13. Use only the AC/DC adaptor supplied with LooK SPOT 2 by Laipac. Using a different AC/DC adaptor will avoid the warranty of the product. REFERENCES 1. "How to Protect Yourself & Others". Centers for Disease Control and Prevention (CDC). 8 April 2020. Archived from the original on 26 February 2020. Retrieved 9 April 2020. 2. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. US Department of Health and Human Services, CDC, N.I.H., Washington, DC (2007). 3. D. B. Larremore et al., Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance. medRxiv https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v3 (27 June 2020). 4. C. B. F. Vogels et al., SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. medRxiv https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1 (4 August 2020). 5. Scohy et al., Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J. Clin. Virol. 129, 104455 (2020). 6. US Food and Drug Administration, Template for manufacturers of molecular and antigen diagnostic COVID-
19 tests for non-laboratory use (Food and Drug Administration, Silver Spring, MD, 2020). 20 | P a g e In vitro diagnostic medical device Prescription use only Consult instructions for use Authorized Representative in the European Community Label/Symbol Description Manufacturer Temperature limitation Product Expiration Date Humidity limitation Serial Number Catalog Number Warning/Caution 21 | P a g e Waste electrical and electronic equipment (WEEE) Ultraviolet Radiation Potential Biohazard Safety Precautions for LooK SPOT 2 The LooK SPOT 2 is designed to provide safe and reliable operation when used according to this Instruction of Use. All warnings and precautions should be followed in order to avoid unsafe actions that could potentially result in personal injury or damage to the device. Warning!
To reduce the risk of electrical shock:
Do not immerse in water or cleaning solutions. Ultraviolet Radiation!
To reduce the risk of UV Exposure:
Do not attempt to open or disassemble LooK SPOT 2 Do not attempt to look inside LooK SPOT 2 while operating or use protective glasses Product tested against EN62471 Failure to follow these warnings will invalidate the warranty. Potential Biohazard!
To reduce the risk of biohazard:
Dispose of used specimens in accordance with Federal, State and Local requirements. Treat specimens and patient samples as potentially biohazardous material. 22 | P a g e Ensure the LooK SPOT 2 is cleaned by using the solution with 70% alcohol. Seek specific training or guidance if you are not experienced with specimen collection and handling procedures. Use of Nitrile, Latex, or other gloves is recommended when handling patient samples. Caution!
To reduce the risk of incorrect results:
The LooK SPOT 2 should only be used by trained operators. Do not use if the LooK SPOT 2 is reporting an error condition that cannot be corrected. To obtain accurate results, refer to the Instruction of Use on specific topics. Use the test kit within the expiration date. To reduce the risk of LooK SPOT 2 damage:
The LooK SPOT 2 is designed for countertop operation. The LooK SPOT 2 is not designed to withstand moisture, extreme humidity, or extreme temperatures for a longer period. The LooK SPOT 2 is not designed to withstand severe shock or vibration. Do not open or disassemble the device. Failure to follow the precautions mentioned above will invalidate the warranty. To reduce the risk of environmental contamination:
Contact Laipac Technical Support at +1-905-604-3759 for a return or disposal of the LooK SPOT 2. Clean the LooK SPOT 2 per the Instruction of Use prior to return or disposal. The LooK SPOT 2 must be disposed of in a safe and compliant manner. Applicable Federal, State and Local regulatory requirements shall be followed to ensure the LooK SPOT 2 is not disposed of as municipal waste. If you are unsure of the proper methods for disposal, contact a certified waste broker for guidance. Note: Medical equipment that may have come into contact with potentially infectious materials (e.g., patient samples, blood, serum, etc.) must be properly decontaminated prior to disposal or recycling. 23 | P a g e ORDERING & CONTACT INFORMATION Reorder Numbers:
1. 105C LooK SPOT 2 (1) 2. 105B LooK COVID-19 Antigen Rapid Test (10 tests) LooK SPOT 2 Dimension and Weight:
Package: L 10 x W 8.5 x H 7.5 Gross weight: 5.5 LB Device: L 7.8 x W 5.0 x H 4.8 Net weight: 3.5 LB Laipac Technology Inc. 25 Valleywood Dr. Unit 11 Markham Ontario L3R 5L9 Canada Tel: +1-905-604-3759 email: info@laipac.com https://www.laipac.com Nasal Swabs Puritan Medical Products Company LLC 31 School Street, Guilford, Maine 04443-0149 USA Tel: +1-207-876-3311 24 | P a g e LEGAL INFORMATION FCC Statement (USA) / Part 15 of the FCC Rules The LooK SPOT 2 has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no warranty that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Connect the equipment to an outlet on a circuit different from that to which the receiver is Increase the separation between the equipment and receiver. connected. Consult the dealer or an experienced radio or television technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. WARNING! Exposure to Radio Frequency Radiation: the radiated output power of this device is below the FCC and Industry Canada radio frequency exposure limits. This device must not be co-located or operating in conjunction with any other antenna or transmitter. FCC requires the user to be notified that any changes or modifications made to this device that are not expressly approved by the manufacturer may void the user's authority to use the device. RSS Canada This device complies with Industry Canada's license-exempt RSS standards. Operation is subject to the following two conditions:
1. This device may not cause interference; and 2. This device must accept any interference, including interference that may cause undesired operation of the Cet appareil est conforme aux normes RSS sans licence dIndustrie Canada. Son fonctionnement est soumis aux deux conditions suivantes:
1. Cet appareil ne doit pas provoquer d'interfrences; et 2. Cet appareil doit accepter toute interfrence, y compris les interfrences susceptibles d'entraner un fonctionnement indsirable de l'appareil. 25 | P a g e device. RF Radiation Exposure Statement:
1. To comply with the Canadian RF exposure compliance requirements, this device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter. 2. For body-worn operation, this device has been tested and meets RF exposure guidelines when used with an accessory that contains no metal. Use of other accessories may not ensure compliance with RF exposure guidelines. Dclaration de l'exposition aux radiations RF:
1. Pour se conformer aux exigences de conformit RF canadienne l'exposition, cet appareil et son antenne ne doivent pas tre co-localiss ou fonctionnant en conjonction avec une autre antenne ou transmetteur. 2. Pour le fonctionnement du corps, cet appareil a t test et rpond aux directives d'exposition RF lorsqu'il est utilis avec un accessoire qui ne contient pas de mtal. Utilisation d'autres accessoires peut ne pas assurer le respect des directives d'exposition RF. ICES-003 (Canada) This digital apparatus does not exceed the Class B limits for radio noise emissions from digital apparatus set out in the interference-causing equipment standard entitled: "Digital Apparatus", ICES-003 of the Canadian Department of Communications. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Cet appareil numrique respecte les limites bruits radiolectriques applicables aux appareils num- riques de classe B prescrites dans la norme sur le matriel brouilleur: Appareils Numriques, NMB-003 dicte par le ministre canadien des Communications. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux condi- tions suivantes:
(1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. EUROPE Document dated 29/10/2021 26 | P a g e
1 2 | TE-CERT211100038-01 STC User manual 2 | Users Manual | 183.86 KiB | December 20 2021 / June 22 2022 | delayed release |
LooK SPOT 2 The New Hero Has Arrived 1. MOST Powerful & Fast Quad-core A72 64-bit processor @ 1.5GHz High-resolution cameras built-in with sensors Processing 5 tests simultaneously Test result ready within 5 to 8 minutes SPEED mode with test result within 30 seconds 2. MOST Simple To Use No skill required to operate Training video of 5 min Patients receive test results in real-time AC110-220V and WiFi connection are required 3. MOST Accurate 97.4% Sensitivity 98.3% Specificity Hazard proof Contact Information Laipac Technology Inc. Ontario Canada Tel: +1-905-7621228 sales@laipac.com The Fastest COVID-19 Antigen Rapid Test AI Machine for Point of Care MSRP USD 1,890 Made in Canada Designed and manufactured by Laipac Technology Inc. 5 Reasons to Consider the LooK SPOT 2 MOST Powerful & Fast MOST Simple To Use MOST Accurate MOST Intelligent Price Price Performance LEADER 4. MOST Intelligent AI Cloud for image analysis Capability to process millions of images daily API to deliver test results in real-time to MoH or corporations 5. Price Performance LEADER No visual interpretation required Best investment for return to work No competitions in the same category Aggressive pricing per test
1 2 | TE-CERT211100038-01 STC Internal photos | Internal Photos | 1.18 MiB | December 20 2021 / June 22 2022 | delayed release |
1 2 | TE-CERT211100038-01 STC External photos | External Photos | 497.44 KiB | December 20 2021 / June 22 2022 | delayed release |
1 2 | TE-CERT211100038-02 Label & Label Location 1217 | ID Label/Location Info | 86.78 KiB | December 20 2021 / December 23 2021 |
LooK SPOT 2 Part #: 105C_ Model #: Look SPOT 2 BOTTOM OF THE DEVICE Rating: 12VDC MAX08A Made in Canada
[=] [=] (01) 812244000025
"MM (17) 260122
"EH (10) 032021B
[=] (21) 630001001 FEICCEDZA FCC ID: TET-LOOKSPOT2 ISED ID: 11280A-LOOKSPOT2 Laipac Technology Inc. 25 Valleywood Drive Unit 11 Markham, ON L3R 5L9 Canada
1 2 | TE-CERT211100038-01 Form Applicant Declaration Letter Rev0 | Cover Letter(s) | 212.76 KiB | December 20 2021 / December 23 2021 |
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration 25 Valleywood Drive Unit11, Markham, Ontario, Canada, L3R 5L9 Applicant Legal Business Name Laipac Technology Inc Address Grantee Code FCC ID Contact Email Contact Phone Authorized Contact Name TET TET-LOOKSPOT2 Diego Lai info@laipac.com
(905) 604-3759 a) b) c) d) e) I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;
in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
(1)
(2)
(3) labeling the equipment with the exact FCC ID as specified in this application, compliance statement labeling pursuant to the applicable rules, compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1)
(2)
(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Applicant Signature:
Date:11/15/2021 Print Name:
Title:
Diego Lai CEO
*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database ApplicantDeclaration Rev:0.0
1 2 | TE-CERT211100038-01 Form SGS FCC Confidentiality Request Letter | Cover Letter(s) | 221.50 KiB | December 20 2021 / December 23 2021 |
Laipac Technology Inc. Date: November 15, 2021 Regarding:
Confidentiality Request regarding application for FCC ID: TET-LOOKSPOT2 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. To:
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States Schematic(s) Block Diagrams Operational Descriptions External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, DiegoB.S.Lai CoFounder&CEO 25 Valleywood Dr. Unit 11 Markham Ontario L3R 5L9 Canada Tel: +1-905-604-3759 E-mail: info@laipac.com http://www.laipac.com
1 2 | TE-CERT211100038-01 Form SGS FCC agent auth letter | Cover Letter(s) | 206.00 KiB | December 20 2021 / December 23 2021 |
Laipac Technology Inc. Date: November 15, 2021 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: TET-LOOKSPOT2 To whom it may concern:
We, the undersigned, hereby authorize SGS Taiwan Ltd. to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Laipac Technology Inc This authorization is valid until further written notice from the applicant. Sincerely, DiegoB.S.Lai CoFounder&CEO On behalf of Company: Laipac Technology Inc Telephone: (905) 604-3759 25 Valleywood Dr. Unit 11 Markham Ontario L3R 5L9 Canada Tel: +1-905-604-3759 E-mail: info@laipac.com http://www.laipac.com
1 2 | TE-CERT211100038-01 STC Test setup photos for 13.56MHz NFC | Test Setup Photos | 847.45 KiB | December 20 2021 / June 22 2022 | delayed release |
1 2 | TE-CERT211100038-01 TR E2-2021-80083 P15.225+RSS 210 13.56MHz NFC | Test Report | 1.34 MiB | December 20 2021 / December 23 2021 |
1 2 | TE-CERT211100038-02 E2-2021-80084 FCC+IC 20cm 1217 | RF Exposure Info | 323.85 KiB | December 20 2021 / December 23 2021 |
1 2 | TE-CERT211100038-01 Form WIFI ch 12 -13 Declaration letter | Cover Letter(s) | 182.49 KiB | December 20 2021 / December 23 2021 |
Laipac Technology Inc. WIFI Channel 12 & 13 Declaration Letter Date:2021/11/15 To: FederalCommunicationCommission EquipmentAuthorizationBranch 7435OaklandMillsRoad Columbia,MID21046 RegardingFCCID:TETLOOKSPOT2 Towhoitmayconcern,wehavedeclaredbelowfeaturedforFCCequipmentauthorizationin regardto802.11b/g/nchannel12&13operatingcapability. Producthardwaredoesnothavethecapabilitytooperateonchannel12&13. Producthardwarehasthecapabilitytooperateonchannel12&13. However,these2channelswillbedisabledviasoftwareanduserwillnotableto enablethese2channels Producthardwarehasthecapabilitytooperateonchannel12&13. AndmeetingKDB594280D01requirement. Complianceisdemonstratedintestreportasthemaximumtransmitpoweris properlyadjustedtocomplywiththeoutofbandemissionrequirementsinPart 15.247.ThedeviceisaWiFiclientdevicethatisnotabletooperateatdifferent powerlevelsasthedefaultsetting,whichisnotaccessibletothirdparty. Others Plsexplaindetailhere. Please check Sincerely, DiegoB.S.Lai CoFounder&CEO 25 Valleywood Dr. Unit 11 Markham Ontario L3R 5L9 Canada Tel: +1-905-604-3759 E-mail: info@laipac.com http://www.laipac.com
1 2 | TE-CERT211100038-01 STC Test setup photos for WLAN | Test Setup Photos | 1.07 MiB | December 19 2021 / June 22 2022 | delayed release |
1 2 | TE-CERT211100038-01 TR E2-2021-80082 P15.247+RSS-247 WLAN | Test Report | 4.23 MiB | December 20 2021 / December 23 2021 |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-12-23 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
2 | 2422 ~ 2452 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2021-12-23
|
||||
1 2 | Applicant's complete, legal business name |
Laipac Technology Inc.
|
||||
1 2 | FCC Registration Number (FRN) |
0013648225
|
||||
1 2 | Physical Address |
25 Valleywood Drive Unit 11
|
||||
1 2 |
Markham, Ontario, N/A
|
|||||
1 2 |
Canada
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
TET
|
||||
1 2 | Equipment Product Code |
LOOKSPOT2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
D******** L********
|
||||
1 2 | Title |
CEO
|
||||
1 2 | Telephone Number |
905-7********
|
||||
1 2 | Fax Number |
905-7********
|
||||
1 2 |
d******@laipac.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
SGS Taiwan Ltd.
|
||||
1 2 | Name |
J****** C********
|
||||
1 2 | Physical Address |
No. 134, Wu Kung Rd., New Taipei Industrial Park
|
||||
1 2 |
New Taipei City, 24803
|
|||||
1 2 |
Taiwan
|
|||||
1 2 | Telephone Number |
+886 ******** Extension:
|
||||
1 2 | Fax Number |
886 2********
|
||||
1 2 |
j******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
SGS Taiwan Ltd.
|
||||
1 2 | Name |
J******** C****
|
||||
1 2 | Physical Address |
No. 134, Wu Kung Rd., New Taipei Industrial Park
|
||||
1 2 |
New Taipei City, 24803
|
|||||
1 2 |
Taiwan
|
|||||
1 2 | Telephone Number |
+886 ******** Extension:
|
||||
1 2 | Fax Number |
886 2********
|
||||
1 2 |
j******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 06/22/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | LooK SPOT 2 | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output Power listed is conducted. The antenna used for this transmitter must be installed to provide a separation distance of at least 20cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Users and installers must be provided with antenna installation instructions and transmitting operating conditions for satisfying RF exposure compliance. This device supports 20MHz and 40MHz bandwidth modes. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
SGS Taiwan Ltd. Central RF Lab
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1 2 | Name |
R**** W******
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1 2 | Telephone Number |
+886-******** Extension:
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1 2 |
r******@sgs.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 13.56000000 | 13.56000000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2412 | 2462 | 0.1803 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15C | CC | 2422 | 2452 | 0.1758 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC