(386 days)
Not Found
No.
The device description clearly indicates it is a "lateral flow chromatographic immunoassay" which relies on chemical reactions and visual interpretation, not computational models or AI. The document does not mention any AI, DNN, or ML components.
No
This device is a diagnostic test intended for the detection of SARS-CoV-2 antigens, not for therapeutic purposes. It provides information about the presence of a virus, which can aid in diagnosis, but it does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19." The process of detecting the presence or absence of a disease (in this case, COVID-19) is a diagnostic function.
No
The device is a lateral flow immunoassay, which is a physical diagnostic kit. It is visually read and detects antigens physically present on a test strip, not through software processing of data. The device description details the physical components and chemical reactions involved in the detection, with no mention of software components.
Yes
The device is described as a "rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens." This involves the examination of human body samples (nasal swabs) to provide information for diagnosis of a disease (COVID-19), which is the definition of an In Vitro Diagnostic (IVD).
N/A
Intended Use / Indications for Use
The OHC COVID-19 Antigen Self Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.
This test is for non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out infection with SARS-CoV-2 or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from June 2023 to July 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations when a new virus or variant is suspected.
Product codes
QYT
Device Description
The OHC COVID-19 Antigen Self Test is a lateral flow chromatographic immunoassay intended to detect the nucleocapsid protein antigen from SARS-CoV-2 in non-prescription home use from:
- Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.
- Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.
The OHC COVID-19 Antigen Self Test is based on a lateral flow immunoassay and detects the N-Protein (nucleocapsid protein) of SARS-CoV-2. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies on test line. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies are bound to colloidal gold. When the sample is loaded to the sample inlet, SARS-CoV-2 antibodies, that were conjugated with the small colloidal gold articles, and SARS-CoV-2 antigen complexes are formed and travel up the strip. If the sample contains SARS-CoV-2 antigens ("analyte"), the complexes will be captured by coated antibodies on membrane to form an analyte-labeled antibody complex. When these complexes reach the test line of the cassette they are retained by another set of SARS-CoV-2 antibodies. This so-called sandwich complex appears as a visible pink/purple line on the test line (T). The presence of SARS- CoV-2 antigen will be indicated by a visible red test line in T-marked (T) position on side of result window. If the sample does not contain SARS-CoV-2 antigens, no sandwich complexes are formed and thus no colored line appears on the test line (T). Regardless of the presence or absence of SARS-CoV-2 antigens in the sample, a colored line will appear on the control line (C). The control (C) line appears in each result window when sample has flowed through the strip. The control line is used as an internal procedural control. The control line should always appear if the test procedure is performed properly and the reagents are working as intended. If no colored line appears on the control line (C), it implies that the test has not worked as intended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior nasal swab specimens
Indicated Patient Age Range
individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.
Intended User / Care Setting
Home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older. Non-prescription.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Limit of Detection (LoD):
The LoD was determined using heat-inactivated SARS-CoV-2 (isolate USA/MD-HP20874/2021) in negative standard material (pooled nasal wash).
- Preliminary LoD Study: Five serial dilutions of the virus were tested in 5 replicates on 3 lots of the assay.
- Confirmatory LoD Study: The preliminary LoD concentration, and concentrations above and below, were tested with 20 replicates for each of 3 kit lots.
- Result: The limit of detection for the OHC COVID-19 Antigen Self Test was determined to be 2.51 x 10³ TCID₅₀/mL.
- International Standard for SARS-CoV-2 antigen (NIBSC code: 21/368) LoD: Confirmed LoD was 1,000 IU/mL, equivalent to 50 IU/swab.
Inclusivity (Analytical Reactivity):
Demonstrated with 9 additional strains/isolates of SARS-CoV-2 virus. Heat-inactivated isolates were diluted into negative standard material and tested in 5 replicates until two consecutive dilutions produced one or more negative replicates.
Wet Testing JN.1:
The JN.1 live pool 1, derived from Emory University clinical samples, was diluted, and five (5) replicates of OHC COVID-19 Antigen Self Test were evaluated.
Cross Reactivity/Microbial Interference:
Evaluated by testing various microorganisms, viruses, and negative matrix. Each was tested in 3 replicates in the absence and presence of 5.01 x 10³ TCID₅₀/mL of heat-inactivated SARS-CoV-2. Cross-reactivity and microbial interference was observed with SARS-coronavirus (rAg) at 1 μg/mL, but not at 0.001 μg/mL.
Interfering Substances:
Twenty-five (25) potentially interfering substances were evaluated in 3 replicates in the presence and absence of 5.01 x 10³ TCID₅₀/mL of heat-inactivated SARS-CoV-2. None interfered at the tested levels, except Mupirocin (nasal ointment) which caused false negatives at 10mg/mL in SARS-CoV-2 positive samples, but not at 5mg/mL.
Hook Effect:
50 µl of heat-inactivated SARS-CoV-2 (5.01 x 10⁵ TCID₅₀/mL) was added to 5 swabs and tested. The device did not display a Hook Effect.
Flex Studies:
A series of flex studies were performed by testing SARS-CoV-2 negative and positive (2xLoD) samples under various conditions (e.g., non-level surface, temp/humidity extremes, swab mixing, light conditions, sample volume, pouch stability, moving cassette, reading time, buffer spill). The results demonstrated robustness.
Precision:
- Study 1: Lot-to-lot precision evaluated using 3 product lots. Contrived samples (negative, 1xLoD, 4xLoD) tested in triplicate in 2 events/day over 10 days by 2 operators.
- Results: 100% agreement for negative, low positive, and moderate positive for all lots and readers.
- Study 2: Between-lot variability evaluated with a randomized test panel (0.75X LoD, 4X LoD, negative sample) over 3 consecutive days. 3 lots x 2 operators/lot x 3 days/operator x 2 runs/day x 2 replicates/run (72 total tests/sample level).
- Results: 100% agreement for negative and moderate positive for all lots and readers. Low positive (0.75xLoD) showed agreement between 69.4% and 72.2%.
Clinical Evaluation:
- Study Type: Prospective clinical study.
- Sample Size: 709 evaluable subjects (59.4% female, 40.6% male) with COVID-19 symptoms within 6 days of symptom onset.
- Data Source: Samples collected by lay users from themselves or a household member at 4 sites in the United States.
- Comparator: Highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay.
- Key Results:
- Positive Percent Agreement (PPA): 85.3% (95% CI: 78.1%-90.4%)
- Negative Percent Agreement (NPA): 99.3% (95% CI: 98.2%-99.7%)
Key Metrics
- Positive Percent Agreement (PPA): 85.3% (95% CI: 78.1%-90.4%)
- Negative Percent Agreement (NPA): 99.3% (95% CI: 98.2%-99.7%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
FDA 510(k) Clearance Letter - OHC COVID-19 Antigen Self Test
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
Osang LLC
℅ Lisa Baumhardt
Senior Medical Device Regulatory Expert
Hyman, Phelps & McNamara P.C.
700 Thirteenth Street, N.W., Suite 1200
Washington, District of Columbia 20005-5929
Re: K241313
Trade/Device Name: OHC COVID-19 Antigen Self Test
Regulation Number: 21 CFR 866.3984
Regulation Name: Over-The-Counter Test To Detect SARS-Cov-2 From Clinical Specimens
Regulatory Class: Class II
Product Code: QYT
Dated: May 7, 2024
Received: May 9, 2024
Dear Lisa Baumhardt:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K241313 - Lisa Baumhardt Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K241313 - Lisa Baumhardt Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Silke Schlottmann -S
Digitally signed by Silke Schlottmann -S
Date: 2025.05.30 17:50:27 -04'00'
Silke Schlottmann
Deputy Assistant Director
Bacteriology Respiratory and Medical Countermeasures Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K241313
Device Name: OHC COVID-19 Antigen Self Test
Indications for Use (Describe):
The OHC COVID-19 Antigen Self Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.
This test is for non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out infection with SARS-CoV-2 or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from June 2023 to July 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations when a new virus or variant is suspected.
Type of Use (Select one or both, as applicable):
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
OHC COVID-19 Antigen Self Test
510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the following 510(k) Summary for OHC COVID-19 Antigen Self Test is provided:
Submitter Information
Applicant/Submitter: OSANG Healthcare Co., Ltd.
132, Anyangcheondong-Ro
Dongan-Gu
Anyang-Si, Gyeonggi-Do, Republic of Korea
14040 Phone: 82-31-4600415
Date Prepared: May 7, 2024
Contact Person: Lisa Baumhardt, Sr. Medical Device Regulatory Consultant
Hyman, Phelps, & McNamara, P.C.
Phone: 202-424-9631
Email: lbaumhardt@hpm.com
Secondary Contact: Seungyeob Lee
OSANG LLC
625 Fair Oaks Ave, Ste 360,
South Pasadena, CA 91030
Phone: 213-800-1820
Email: dan@osangllc.com
Identification of the Device
Trade Name: OHC COVID-19 Antigen Self Test
Common Name: Over-the-Counter COVID-19 Antigen Test
Classification Name: Over-the-Counter COVID-19 Antigen Test
21 C.F.R. 866.3984
Product Code: QYT
Device Class: Class II
Predicate Device(s)
Predicate Device(s): Flowflex COVID-19 Antigen Home Test (K230828)
Intended Use/ Indications for Use
The OHC COVID-19 Antigen Self Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.
This test is for non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.
Page 6
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out infection with SARS-CoV-2 or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from June 2023 to July 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations when a new virus or variant is suspected.
Device Description
The OHC COVID-19 Antigen Self Test is a lateral flow chromatographic immunoassay intended to detect the nucleocapsid protein antigen from SARS-CoV-2 in non-prescription home use from:
- Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.
- Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.
The OHC COVID-19 Antigen Self Test is based on a lateral flow immunoassay and detects the N-Protein (nucleocapsid protein) of SARS-CoV-2. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies on test line. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies are bound to colloidal gold. When the sample is loaded to the sample inlet, SARS-CoV-2 antibodies, that were conjugated with the small colloidal gold articles, and SARS-CoV-2 antigen complexes are formed and travel up the strip. If the sample contains SARS-CoV-2 antigens ("analyte"), the complexes will be captured by coated antibodies on membrane to form an analyte-labeled antibody complex. When these complexes reach the test line of the cassette they are retained by another set of SARS-CoV-2 antibodies. This so-called sandwich complex appears as a visible pink/purple line on the test line (T). The presence of SARS- CoV-2 antigen will be indicated by a visible red test line in T-marked (T) position on side of result window. If the sample does not contain SARS-CoV-2 antigens, no sandwich complexes are formed and thus no colored line appears on the test line (T). Regardless of the presence or absence of SARS-CoV-2 antigens in the sample, a colored line will appear on the control line (C). The control (C) line appears in each result window when sample has
Page 7
flowed through the strip. The control line is used as an internal procedural control. The control line should always appear if the test procedure is performed properly and the reagents are working as intended. If no colored line appears on the control line (C), it implies that the test has not worked as intended.
Substantial Equivalence
The proposed OHC COVID-19 Antigen Self Test has similar indications for use, and uses the same fundamental technology as, the legally marketed predicate device to which substantial equivalence is claimed, the Flowflex COVID-19 Antigen Home Test (K230828).
Table 1. Comparison of the Proposed Device, Predicate Device and Reference Devices
| Specification | Proposed Device: OHC COVID-19 Antigen Self Test | Predicate Device: Flowflex COVID-19 Antigen Home Test K230828 |
|---|---|---|
| Intended Use | Over-the-counter test to detect SARS-CoV-2 from clinical specimens. | Over-the-counter test to detect SARS-CoV-2 from clinical specimens. |
| Indications for Use | The OHC COVID-19 Antigen Self Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. |
This test is for non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test for SARS-CoV-2 using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out infection with SARS-CoV-2 or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from June 2023 to | The Flowflex COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID19 within the first 6 days of symptom onset.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare |
Page 8
| Specification | Proposed Device: OHC COVID-19 Antigen Self Test | Predicate Device: Flowflex COVID-19 Antigen Home Test K230828 |
|---|---|---|
| July 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations when a new virus or variant is suspected. | provider. |
The performance characteristics for SARS-CoV-2 were established from December 2022 to March 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected. |
| Prescription Use or Over-the-Counter | Over-the-counter (OTC) | Over-the-counter (OTC) |
| End User | Lay User | Lay User |
| Disease | COVID-19 | COVID-19 |
| Intended Use Population | Symptomatic individuals 14 years of age and older testing themselves and adults testing individuals aged 2 years and older. | Symptomatic individuals 14 years of age and older testing themselves and adults testing individuals aged 2 years and older |
| Sample | Anterior nasal swab specimen | Anterior nasal swab specimen |
| Assay Principle | Lateral Flow | Lateral Flow |
| Qualitative or Quantitative | Qualitative | Qualitative |
| Organism detected | SARS-CoV-2 | SARS-CoV-2 |
| Format | Test cassette | Test cassette |
| Controls | Internal control | Internal control |
| Time to Result | 15 minutes | 15-30 minutes |
| Results | Positive, Negative, or Invalid | Positive, Negative, or Invalid |
| Interpretation | Visually read | Visually read |
Technological Characteristics
As shown in Table 1 above, the proposed device, OHC COVID-19 Antigen Self Test, and the predicate device have the same intended use and similar indications for use. The proposed device, OHC COVID-19 Antigen Self Test and the predicate device have the same technological characteristics. Both devices are lateral flow immunoassays which are visually read and require no instrumentation or mobile applications. Both devices detect the SARS-CoV-2 nucleocapsid protein from a lay user collected anterior swab specimen from individuals with signs and
Page 9
symptoms of COVID-19.
Performance Data
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the proposed device, OHC COVID-19 Antigen Self Test and the predicate device. The performance studies included:
Limit of Detection:
The Limit of Detection (LoD) of the OHC COVID-19 Antigen Self Test was determined by evaluating different dilutions of heat-inactivated SARS-CoV-2 (isolate USA/MD-HP20874/2021 in a negative standard material (pooled nasal wash). The LoD was determined as the lowest virus concentration that was detected >95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive). The limit of detection was established in two phases.
Preliminary LoD Study:
Five serial dilutions were made from heat-inactivated SARS-CoV-2 virus (isolate USA/MD-HP20874/2021) into negative standard material (pooled nasal wash). Five replicates of each serial dilution were tested on 3 lots of the assay to determine the preliminary LoD concentration of the device. The lowest concentration with 5/5 positive results from each lot was considered the preliminary LoD of the virus strain. For each replicate 50 µl of the virus dilution was applied to the swab and the swab was processed according to the Instructions for Use. The results are summarized below in Table 2:
Table 2. Preliminary LoD
| Concentration of SARS-CoV2 (USA/MD-HP20874/2021) applied to dry swab | Lot 1: O1SHY004 | Lot 2: 01SHZ005 | Lot 3: 01SHY006 |
|---|---|---|---|
| 5.01 x 10⁴ TCID₅₀/mL | 5/5 | 5/5 | 5/5 |
| 5.01 x 10³ TCID₅₀/mL | 5/5 | 5/5 | 5/5 |
| 2.51 x 10³ TCID₅₀/mL | 5/5 | 0/5 | 5/5 |
| 5.01 x 10² TCID₅₀/mL | 0/5 | 5/5 | 0/5 |
| 1.26 x 10³ TCID₅₀/mL | 0/5 | 0/5 | 0/5 |
| 0.63 x 10³ TCID₅₀/mL | 0/5 | 0/5 | 0/5 |
Confirmatory LoD Study:
The Preliminary LoD concentration and at concentrations above and below the LoD were tested with a total of twenty (20) replicates of the same heat-inactivated SARS-CoV-2 material for each of 3 kit lots. To confirm the LoD for each lot, at least 19 of the 20 replicates should be positive. The final confirmation data set included the confirmed LoD level with at least on additional level tested above and below to demonstrate that the levels above the LoD were 100% positive and the levels below the LoD were