Flowflex Plus RSV + Flu A/B + COVID Home Test
FDA 510(k) K251749 · ACON Laboratories, Inc.
510(k) numberK251749
Submission
- Device name
- Flowflex Plus RSV + Flu A/B + COVID Home Test
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- June 6, 2025
- Decision date
- October 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- SCA – Multi-Analyte Respiratory Virus Antigen Detection Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3987
- Specialty
- Microbiology
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.
Other 510(k)s with product code SCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA · Dual Track | ACON Laboratories, Inc. | 07/10/2026SE |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProSCA · Traditional | Ihealth Labs, Inc. | 12/12/2025SE |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProSCA · Traditional | Ihealth Labs, Inc. | 12/12/2025SE |
| K251538 | Status COVID-19/Flu A&BSCA · Dual Track | Princeton BioMeditech Corp. | 11/14/2025SE |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA · Traditional | Access Bio, Inc. | 08/22/2025SE |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCA · Traditional | Wondfo USA Co, Ltd. | 08/20/2025SE |
| K243561 | Nano-Check Influenza+COVID-19 Dual TestSCA · Dual Track | Nano-Ditech Corporation | 06/17/2025SE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional | ACON Laboratories, Inc. | 05/10/2025SE |
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B…SCA · Traditional | Wondfo USA Co, Ltd. | 01/16/2025SE |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestSCA · Traditional | Osang, LLC | 01/13/2025SE |
More from Osang, LLC
| 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 |
| 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 |
| K230828 | Flowflex COVID-19 Antigen Home TestQYT · Traditional | 11/09/2023SE |
| 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 Plus RSV + Flu A/B + COVID Home Test cleared by the FDA?
Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) received a 510(k) decision of Substantially Equivalent on October 22, 2025, 138 days after the submission was received.
What is the product code of K251749?
The FDA product code is SCA – Multi-Analyte Respiratory Virus Antigen Detection Test, a Class II (moderate risk) device regulated under 21 CFR 866.3987.