510(k) · Cleared
ClearedFlowflex COVID-19 Antigen Home Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · QYT Over-The-Counter Covid-19 Antigen Test
Cleared on Nov 9, 2023 after a 227-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Nov 9, 2023
- Review
- 227 days
- Class
- Class II
- Product code
- QYT
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 7 citing it directly.
- This deviceK230828 Flowflex COVID-19 Antigen Home TestACON Laboratories, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK241313 OHC COVID-19 Antigen Self TestOsang, LLC · 2025
- Descendant · cites it directly · 1 of its ownK240728 CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK231795 QuickVue COVID-19 TestQuidel Corporation · 2024
- Descendant · cites it directly · 0 of its ownK260754 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen…Assure Tech., LLC · 2026
- Descendant · 2 generations on · 0 of its ownK260095 Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K241313OHC COVID-19 Antigen Self TestOsang, LLC · 2025 · cites it directly1descendant
- K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc. · 2024 · cites it directly1descendant
- K231795QuickVue COVID-19 TestQuidel Corporation · 2024 · cites it directly1descendant
- K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestAssure Tech., LLC · 2026 · cites it directly0descendants
- K260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K230828 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 2023 | — |
| +1 | K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | 2025 | — |
| +1 | K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | 2024 | — |
| +1 | K231795 | QuickVue COVID-19 Test | Quidel Corporation | 2024 | — |
| +1 | K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | 2026 | — |
| +2 | K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QYT device
- #1 K241313 OHC COVID-19 Antigen Self Testscore 12.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241313 | OHC COVID-19 Antigen Self Test | 2025 | 1 |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | 2024 | 1 |
| K231795 | QuickVue COVID-19 Test | 2024 | 1 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | 2026 | 0 |
| K241915 | CareSuperb™ COVID-19 Antigen Home Test | 2025 | 0 |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | 2024 | 0 |
| K233842 | iHealth COVID-19 Antigen Rapid Test | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K241313 (Osang, LLC, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QYT devicesQYT Over-The-Counter Covid-19 Antigen Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QYT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYT
138in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYT
No recall names QYT since 2007.
Adverse event reports per year · QYT
82in 2025
MAUDE reports naming product code QYT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 5 | 179 | 0 | 23 |
| 2025 | 5 | 138 | 0 | 82 |
| 2026 | 3 | 90 | 0 | — |
What is it indicated for?
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…
Read the full statement (260 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K230828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230828: Flowflex COVID-19 Antigen Home Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230828
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026