Cleared Traditional

CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416) - FDA 510(k) Clearance

Class I Microbiology device.

K904416 · Biotrax, Inc. · Microbiology device
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Jun 1991
Decision
270d
Days
Class 1
Risk

K904416 is an FDA 510(k) clearance for the CROATEST (R) RHEUMATOID DIAGNOSTIC. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Biotrax, Inc. (Baltimore, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 270 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - 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 K904416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1990
Decision Date June 24, 1991
Days to Decision 270 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 102d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.