Flowflex® Plus COVID-19 Home Test

K233373 · ACON Laboratories, Inc. · QYT · Apr 19, 2024 · Microbiology

Device Facts

• Record ID: K233373
• Device Name: Flowflex® Plus COVID-19 Home Test
• Applicant: ACON Laboratories, Inc.
• Product Code: QYT · Microbiology
• Decision Date: Apr 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3984
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Flowflex Plus COVID-19 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 COVID-19 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 Plus COVID-19 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 provider. The performance characteristics for SARS-CoV-2 were established during June 2022 to April 2023 when COVID-19 variant 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.

Device Story

Lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen; utilizes anterior nasal swab specimens. Device operates via capillary action; antigen-antibody binding produces visible color change on test strip. Intended for non-prescription home use; operated by lay users (self-test or adult-assisted). Output is visual interpretation of test lines (presence/absence of color). Results provide presumptive status; negative results require serial testing (48-72 hours) if symptoms persist. Assists users in identifying potential SARS-CoV-2 infection; facilitates decision to seek professional medical follow-up. Does not differentiate between SARS-CoV and SARS-CoV-2; does not rule out co-infections.

Clinical Evidence

Prospective all-comers clinical study (n=758 symptomatic subjects) conducted June 2022–April 2023. Comparator: FDA-authorized RT-PCR assay. Results: PPA 91.3% (95% CI: 86.5%–94.5%); NPA 99.3% (95% CI: 98.2%–99.7%). Performance stratified by days post-symptom onset (DPSO) showed 97.2% PPA at day 1, 95.6% at day 2, 95.0% at day 3, 76.7% at day 4, 76.9% at day 5, and 87.5% at day 6.

Technological Characteristics

Lateral flow immunoassay; visual readout; anterior nasal swab specimen; non-electronic; no software; no connectivity.

Indications for Use

Indicated for symptomatic individuals (signs/symptoms of COVID-19 within 6 days of onset) for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. For non-prescription home use by individuals aged 14+ (self-test) or adults testing individuals aged 2+.

Regulatory Classification

Identification

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Submission Summary (Full Text)

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Acon Laboratories, Inc. % James Mullally Vice President, In Vitro Diagnostic Regulatory Affairs Mcra, LLC 803 7th Street NW Washington, District of Columbia 20001

April 19, 2024

Re: K233373

Trade/Device Name: Flowflex Plus COVID-19 Home 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: September 29, 2023 Received: January 22, 2024

Dear James Mullally:

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.

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).

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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 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-safetyreporting-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Silke Schlottmann -S" in a large font. To the right of the name is the text "Digitally signed by Silke Schlottmann -S" and "Date: 2024.04.19 12:52:12 -04'00'". This indicates that the document was digitally signed by Silke Schlottmann on April 19, 2024, at 12:52:12 with a time zone offset of -04'00'.

Silke Schlottmann, Ph.D. 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

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# Indications for Use

510(k) Number (if known) K233373

#### Device Name

Flowflex® Plus COVID-19 Home Test

## Indications for Use (Describe)

The Flowflex Plus COVID-19 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 COVID 19 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 Plus COVID-19 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 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 during June 2022 to April 2023 when COVID-19 variant 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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