K251538 is an FDA 510(k) clearance for the Status™ COVID-19/Flu A&B. This device is classified as a Multi-analyte Respiratory Virus Antigen Detection Test (Class II - Special Controls, product code SCA).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 14, 2025, 179 days after receiving the submission on May 19, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3987. 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..
| 510(k) Number | K251538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 179 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SCA — Multi-analyte Respiratory Virus Antigen Detection Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3987 |
| Definition | 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. |