Cleared Traditional

K910635 - TOTAL BILIRUBIN REAGENT SET

K910635 is the FDA 510(k) clearance for TOTAL BILIRUBIN REAGENT SET by Biochemical Trade, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K910635 · Biochemical Trade, Inc. · Chemistry device
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May 1991
Decision
92d
Days
Class 2
Risk

K910635 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT SET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochemical Trade, Inc. devices

Submission Details

510(k) Number K910635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date May 15, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 173
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K910635.
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc. · Oct 1991
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · Amersham Corp. · Jul 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · Trace Scientific , Ltd. · Jul 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · Roche Diagnostic Systems, Inc. · Apr 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · Roche Diagnostic Systems, Inc. · Apr 1991
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
K904468 · Amresco, Inc. · Jan 1991