Not Cleared Direct

DEN240029 - Healgen Rapid Check COVID-19/Flu A&B Antigen Test (FDA 510(k) Clearance)

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

DEN240029 · Healgen · Microbiology device
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Oct 2024
Decision
122d
Days
Class 2
Risk

DEN240029 is an FDA 510(k) submission (not cleared) for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Classified as Multi-analyte Respiratory Virus Antigen Detection Test (product code SCA), Class II - Special Controls.

Submitted by Healgen (Houston, US). The FDA issued a Not Cleared (DENG) decision on October 7, 2024 after a review of 122 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Healgen devices

Submission Details

510(k) Number DEN240029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 07, 2024
Decision Date October 07, 2024
Days to Decision 122 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 102d · This submission: 122d
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
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