Cleared Traditional

K910635 - TOTAL BILIRUBIN REAGENT SET

K910635 is an FDA 510(k) clearance for TOTAL BILIRUBIN REAGENT SET, manufactured by Biochemical Trade, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K910635

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
Combination Product No
PCCP Authorized No
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.

CIG Device Classification - Class 2, Special Controls

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 216
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