Cleared Dual Track

Status? COVID-19/Flu A&B

K251538 · Princeton BioMeditech Corp. · Microbiology

Nov 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K251538 is an FDA 510(k) clearance for the Status? COVID-19/Flu A&B, 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 review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K251538 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.