Cleared Dual Track

K251538 - Status™ COVID-19/Flu A&B (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K251538 · Princeton BioMeditech Corp. · Microbiology device
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Nov 2025
Decision
179d
Days
Class 2
Risk

K251538 is an FDA 510(k) clearance for the Status™ COVID-19/Flu A&B. Classified as Multi-analyte Respiratory Virus Antigen Detection Test (product code SCA), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 14, 2025 after a review of 179 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3987 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton BioMeditech Corp. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics

Device Classification

Product Code SCA Multi-analyte Respiratory Virus Antigen Detection Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - SCA Multi-analyte Respiratory Virus Antigen Detection Test

All 10
Devices cleared under the same product code (SCA) and FDA review panel - the closest regulatory comparables to K251538.
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Nano-Check Influenza+COVID-19 Dual Test
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