Cleared Traditional

K250377 - Flowflex Plus COVID-19 + Flu A/B Home Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250377 · ACON Laboratories, Inc. · Microbiology device
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May 2025
Decision
89d
Days
Class 2
Risk

K250377 is an FDA 510(k) clearance for the Flowflex Plus COVID-19 + Flu A/B Home 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 May 10, 2025 after a review of 89 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 K250377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2025
Decision Date May 10, 2025
Days to Decision 89 days
Submission Type Traditional
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
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

MCRA
James Mullally

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K250377.
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