Status COVID-19/Flu A&B
FDA 510(k) K251538 · Princeton BioMeditech Corp.
510(k) numberK251538
Submission
- Device name
- Status COVID-19/Flu A&B
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- May 19, 2025
- Decision date
- November 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary 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 |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional | ACON Laboratories, Inc. | 10/22/2025SE |
| 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 |
|---|---|---|
| K182157 | BioSign Flu A+BPSZ · Special | 09/18/2018SE |
| K130650 | Status DS OxyDJG · Traditional | 02/26/2014SE |
| K133474 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 12/10/2013SE |
| K132465 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 09/09/2013SE |
| K083746 | Biosign Flu A+BPSZ · Traditional | 11/10/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | 07/01/2010SE |
| K100341 | Spermcheck FertilityPOV · Traditional | 05/04/2010SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | 10/06/2008SE |
| K073039 | Spermcheck VasectomyPOV · Traditional | 01/24/2008SE |
| K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/AmpLAG · Traditional | 11/26/2007SE |
Questions and answers
When was Status COVID-19/Flu A&B cleared by the FDA?
Status COVID-19/Flu A&B (K251538) received a 510(k) decision of Substantially Equivalent on November 14, 2025, 179 days after the submission was received.
What is the product code of K251538?
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.