Flowflex COVID-19 Antigen Home Test
FDA 510(k) K230828 · ACON Laboratories, Inc.
510(k) numberK230828
Submission
- Device name
- Flowflex COVID-19 Antigen Home Test
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- March 27, 2023
- Decision date
- November 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QYT – Over-The-Counter Covid-19 Antigen Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3984
- Specialty
- Microbiology
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Other 510(k)s with product code QYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | Assure Tech., LLC | 06/05/2026SE |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-TestQYT · Traditional | Healgen Scientific,, LLC | 04/13/2026SE |
| K251916 | GenBody COVID-19 Ag Home TestQYT · Traditional | Genbody.Inc. | 03/13/2026SE |
| K251595 | COVID-19 Detect Rapid Self -TestQYT · Traditional | InBios International, Inc. | 10/12/2025SE |
| K251753 | GenaCheck COVID-19 Rapid Self-TestQYT · Traditional | Genabio Diagnostics, Inc. | 09/05/2025SE |
| K241313 | OHC COVID-19 Antigen Self TestQYT · Traditional | Osang, LLC | 05/30/2025SE |
| K243518 | BinaxNOW COVID-19 Antigen Self TestQYT · Traditional | Abbott Diagnostics Scarborough, Inc. | 02/11/2025SE |
| K241915 | CareSuperb COVID-19 Antigen Home TestQYT · Traditional | Access Bio, Inc. | 01/29/2025SE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/30/2024SE |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT · Traditional | CorDx, Inc. | 06/21/2024SE |
More from CorDx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA · Dual Track | 07/10/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | 11/26/2025SE |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional | 10/22/2025SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | 10/10/2025SE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional | 05/10/2025SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | 05/31/2024SE |
| K233373 | Flowflex® Plus COVID-19 Home TestQYT · Traditional | 04/19/2024SE |
| K193318 | Distinct® Early Detection Pregnancy TestLCX · Traditional | 08/20/2020SE |
| K192175 | On Call Express II Blood Glucose Monitoring SystemNBW · Special | 10/17/2019SE |
| K191038 | On Call Express Voice Blood Glucose Monitoring SystemNBW · Special | 06/12/2019SE |
Questions and answers
When was Flowflex COVID-19 Antigen Home Test cleared by the FDA?
Flowflex COVID-19 Antigen Home Test (K230828) received a 510(k) decision of Substantially Equivalent on November 9, 2023, 227 days after the submission was received.
What is the product code of K230828?
The FDA product code is QYT – Over-The-Counter Covid-19 Antigen Test, a Class II (moderate risk) device regulated under 21 CFR 866.3984.