Cleared Traditional

K910591 - ROCHE REAGENT FOR TOTAL BILIRUBIN

K910591 is the FDA 510(k) clearance for ROCHE REAGENT FOR TOTAL BILIRUBIN by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K910591 · Roche Diagnostic Systems, Inc. · Chemistry device
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Apr 1991
Decision
71d
Days
Class 2
Risk

K910591 is an FDA 510(k) clearance for the ROCHE REAGENT FOR TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on April 24, 1991 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K910591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date April 24, 1991
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 154
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K910591.
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 DIRECT BILIRUBIN
K910593 · Roche Diagnostic Systems, Inc. · Apr 1991
COULTER DIRECT BILLRUBIN REAGENT
K905622 · Coulter Electronics, Inc. · Dec 1990
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · Synermed, Inc. · Sep 1990