Not Cleared Direct

DEN230090 - First To Know Syphilis Test (FDA 510(k) Clearance)

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

DEN230090 · Nowdiagnostics · Microbiology device
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Aug 2024
Decision
233d
Days
Class 2
Risk

DEN230090 is an FDA 510(k) submission (not cleared) for the First To Know Syphilis Test. Classified as Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users (product code SBZ), Class II - Special Controls.

Submitted by Nowdiagnostics (Springdale, US). The FDA issued a Not Cleared (DENG) decision on August 16, 2024 after a review of 233 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3986 - 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.

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Submission Details

510(k) Number DEN230090 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 27, 2023
Decision Date August 16, 2024
Days to Decision 233 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 102d · This submission: 233d
Pathway characteristics

Device Classification

Product Code SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3986
Definition Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Is An In Vitro Diagnostic Device Used For Detection Of Antibodies In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Device Is Intended To Aid In Diagnosis Of Syphilis And Intended For Prescription Use Or Over-the-counter Use.
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.