Cleared Dual Track

K261212 - Flowflex Plus RSV + Flu A/B + COVID Rap...

K261212 is the FDA 510(k) clearance for Flowflex Plus RSV + Flu A/B + COVID Rap... by ACON Laboratories, Inc.. It is a Class 2 Microbiology device (product code SCA) cleared through the Dual Track 510(k) pathway after a 87-day FDA review.

K261212 · ACON Laboratories, Inc. · Microbiology device
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Jul 2026
Decision
87d
Days
Class 2
Risk

K261212 is an FDA 510(k) clearance for the Flowflex Plus RSV + Flu A/B + COVID Rapid Test. Classified as Multi-analyte Respiratory Virus Antigen Detection Test (product code SCA), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 10, 2026 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ACON Laboratories, Inc. devices

Submission Details

510(k) Number K261212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2026
Decision Date July 10, 2026
Days to Decision 87 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
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 11
Devices cleared under the same product code (SCA) and FDA review panel - the closest regulatory comparables to K261212.
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · Ihealth Labs, Inc. · Dec 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · Ihealth Labs, Inc. · Dec 2025
Status™ COVID-19/Flu A&B
K251538 · Princeton BioMeditech Corp. · Nov 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · ACON Laboratories, Inc. · Oct 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · Access Bio, Inc. · Aug 2025
WELLlife Flu A&B Home Test
K251563 · Wondfo USA Co., Ltd. · Aug 2025