Cleared Traditional

K230828 - Flowflex COVID-19 Antigen Home Test

K230828 is an FDA 510(k) clearance for Flowflex COVID-19 Antigen Home Test, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Microbiology device with product code QYT cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K230828 · ACON Laboratories, Inc. · Microbiology device
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Nov 2023
Decision
227d
Days
Class 2
Risk

K230828 is an FDA 510(k) clearance for the Flowflex COVID-19 Antigen Home Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2023 after a review of 227 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3984 - 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 ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K230828

510(k) Number K230828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2023
Decision Date November 09, 2023
Days to Decision 227 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
125d slower than avg
Panel avg: 102d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QYT Device Classification - Class 2, Special Controls

Product Code QYT Over-the-counter Covid-19 Antigen Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3984
Definition For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.
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, LLC
James E 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.