# K230828: Flowflex COVID-19 Antigen Home Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Nov 9, 2023 after 227 days
- Product code: QYT (Over-The-Counter Covid-19 Antigen Test)
- Device class: 2
- Regulation: 21 CFR 866.3984
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K241313: OHC COVID-19 Antigen Self Test (2025), 1 descendant of its own
- K240728: CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (2024), 1 descendant of its own
- K231795: QuickVue COVID-19 Test (2024), 1 descendant of its own
- K260754: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (2026), 0 descendants of its own
- K260095: Heal-Check Rapid COVID-19 Antigen Self-Test (2026), 0 descendants of its own

## Indications for use
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 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 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 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.

Source page: https://510kreport.com/device/K230828
Methodology: https://510kreport.com/methodology