Cleared Traditional

K232377 - Healgen Rapid COVID-19 Antigen Test (FDA 510(k) Clearance)

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

K232377 · Healgen Scientific, LLC · Microbiology device
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Apr 2024
Decision
255d
Days
Class 2
Risk

K232377 is an FDA 510(k) clearance for the Healgen Rapid COVID-19 Antigen Test. Classified as Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings (product code QVF), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 255 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3982 - 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 Healgen Scientific, LLC devices

Submission Details

510(k) Number K232377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2023
Decision Date April 19, 2024
Days to Decision 255 days
Submission Type Traditional
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
153d slower than avg
Panel avg: 102d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3982
Definition A Simple Point-of-care Device To Detect Sars-cov-2 Viral Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections Covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory
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

Axteria Biomed Consulting
Jinjie Hu

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 - QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings

All 7
Devices cleared under the same product code (QVF) and FDA review panel - the closest regulatory comparables to K232377.
WELLlife COVID-19 Antigen Test Rx
K251289 · Guangzhou Wondfo Biotech Co., Ltd. · Oct 2025
BD Veritor System for SARS-CoV-2
K243872 · Becton, Dickinson and Company · Jun 2025
BinaxNOW COVID-19 Ag Card
K250273 · Abbott Diagnostics Scarborough, Inc. · Jun 2025
SCoV-2 Ag Detect Rapid Test
K233358 · InBios International, Inc. · Aug 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · Nano-Ditech Corporation · Jan 2024
Sofia 2 SARS Antigen+ FIA
K233688 · Quidel Corporation · Dec 2023