Cleared Traditional

K801117 - COBAS TOTAL BILIRUBIN REAGENT & DILUENT

K801117 is an FDA 510(k) clearance for COBAS TOTAL BILIRUBIN REAGENT & DILUENT, manufactured by Roche Analytical Instruments, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 28-day FDA review.

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

FDA 510(k) Submission Details - K801117

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.

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 219
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K801117.
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · King Diagnostics, Inc. · Jul 1981
STANBIO BILIRUBIN TEST SET
K810055 · Stanbio Laboratory · Feb 1981
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · American Monitor Corp. · Nov 1980
REAGENTS FOR DETERM. TOTAL BILIRUBIN
K800675 · Diagnostic Solutions, Inc. · May 1980
REAGENT FOR DETERM. DIRECT BILIRUBIN
K800686 · Diagnostic Solutions, Inc. · May 1980
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · Volu Sol Medical Industries · Dec 1979