Cleared Traditional

COBAS TOTAL BILIRUBIN REAGENT & DILUENT (K801117) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801117 · Roche Analytical Instruments, Inc. · Chemistry device
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Jun 1980
Decision
28d
Days
Class 2
Risk

K801117 is an FDA 510(k) clearance for the COBAS TOTAL BILIRUBIN REAGENT & DILUENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Roche Analytical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 28 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 Analytical Instruments, Inc. devices

Submission Details

510(k) Number K801117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date June 09, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 79
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K801117.
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · Sigma Chemical Co. · Aug 1983
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · Beckman Instruments, Inc. · Oct 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · Beckman Instruments, Inc. · Oct 1981
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979
MULTISTAT III, TOTAL BILIRUBIN TEST
K771621 · Instrumentation Laboratory CO · Sep 1977