Flowflex Plus COVID-19 + Flu A/B Home Test

K250377 · ACON Laboratories, Inc. · SCA · May 10, 2025 · Microbiology

Device Facts

• Record ID: K250377
• Device Name: Flowflex Plus COVID-19 + Flu A/B Home Test
• Applicant: ACON Laboratories, Inc.
• Product Code: SCA · Microbiology
• Decision Date: May 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3987
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

Device Story

The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay for home use. Users collect anterior nasal swab specimens, process them in an extraction buffer, and apply the sample to a test cassette. The device uses capillary action to migrate the specimen across a nitrocellulose membrane containing specific antibody-coated colored particles. If viral antigens are present, they form a sandwich complex with the antibodies, resulting in visible colored lines at the test regions (CoV, A, or B). A control line confirms proper sample volume and wicking. Results are visually read by the user at 15 minutes. The test provides qualitative results to aid in the detection of respiratory infections, though negative results are presumptive and require confirmation by a healthcare provider if symptoms persist. The device helps users identify potential SARS-CoV-2 or influenza infections, facilitating timely follow-up care.

Clinical Evidence

Prospective clinical study (Dec 2022–Mar 2024) of 720 evaluable symptomatic subjects compared the device to an FDA-cleared RT-PCR assay. SARS-CoV-2 PPA was 90.4% (95% CI: 85.1–94.3%) and NPA was 99.3% (95% CI: 98.4–99.9%). Influenza A PPA was 91.6% (95% CI: 83.4–96.5%) and NPA was 99.8% (95% CI: 99.1–100%). Influenza B PPA was 93.6% (95% CI: 82.5–98.7%) and NPA was 99.7% (95% CI: 98.9–99.9%). Usability study confirmed 100% correct performance of critical and non-critical tasks by lay users.

Technological Characteristics

Lateral flow immunoassay; qualitative antigen detection; anterior nasal swab specimen collection; visual readout.

Indications for Use

Indicated for symptomatic individuals aged 2 years or older for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in anterior nasal swab specimens. For non-prescription home use.

Regulatory Classification

Identification

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 15, 2025

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

Re: K250377
Trade/Device Name: Flowflex Plus COVID-19 + Flu A/B Home Test
Regulation Number: 21 CFR 866.3987
Regulation Name: Multi-analyte respiratory virus antigen detection test
Regulatory Class: Class II
Product Code: SCA

Dear James Mullally:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 10, 2025. Specifically, FDA is updating this SE Letter as an administrative correction. Specifically, FDA is updating this substantial equivalence (SE) Letter to correct a typo in the device trade name by revising the name from Flowflex Plus COVID-19 and Flu A/B Home Test to Flowflex Plus COVID-19 + Flu A/B Home Test.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Silke Schlottmann, Deputy Assistant Director, [e-mail].

Sincerely,

Silke Schlottmann
-Digitally signed by Silke Schlottmann -5
Date: 2025.05.15 12:05:49 -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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 10, 2025

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

Re: K250377
Trade/Device Name: Flowflex Plus COVID-19 and Flu A/B Home Test
Regulation Number: 21 CFR 866.3987
Regulation Name: Multi-Analyte Respiratory Virus Antigen Detection Test
Regulatory Class: Class II
Product Code: SCA
Dated: February 6, 2025
Received: February 10, 2025

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250377 - James Mullally
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-

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K250377 - James Mullally
Page 3

assistance/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,

Silke Schlottmann-S
Digitally signed by Silke Schlottmann -S
Date: 2025.05.10 00:40:42 -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K250377

Device Name
Flowflex Plus COVID-19 + Flu A/B Home Test

Indications for Use (Describe)
The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.
This test is for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

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)

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