Cleared Traditional

CROMATEST SYPHILIS DIAGNOSTIC (K904496) - FDA 510(k) Clearance

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

K904496 · Biotrax, Inc. · Microbiology device
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Jul 1991
Decision
295d
Days
Class 2
Risk

K904496 is an FDA 510(k) clearance for the CROMATEST SYPHILIS DIAGNOSTIC. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Biotrax, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 295 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - 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 Biotrax, Inc. devices

Submission Details

510(k) Number K904496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date July 24, 1991
Days to Decision 295 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 102d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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 - GMQ Antigens, Nontreponemal, All

All 31
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