Cleared Traditional

K904496 - CROMATEST SYPHILIS DIAGNOSTIC

K904496 is an FDA 510(k) clearance for CROMATEST SYPHILIS DIAGNOSTIC, manufactured by Biotrax, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

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

FDA 510(k) Submission Details - K904496

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.

GMQ Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K904496.
TRUST
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SYPH-TRUST
K863368 · I.A.F. Production, Inc. · Dec 1986
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