Cleared Traditional

K896232 - COBAS READY TOTAL BILIRUBIN REAGENT

K896232 is an FDA 510(k) clearance for COBAS READY TOTAL BILIRUBIN REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K896232 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
120d
Days
Class 2
Risk

K896232 is an FDA 510(k) clearance for the COBAS READY TOTAL BILIRUBIN REAGENT. 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 February 27, 1990 after a review of 120 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K896232

510(k) Number K896232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date February 27, 1990
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K896232.
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
K900571 · American Research Products Co. · Apr 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · Em Diagnostic Systems, Inc. · Mar 1990
OLYMPUS DIRECT BILIRUBIN
K897175 · Em Diagnostic Systems, Inc. · Mar 1990
DIRECT BILIRUBIN REAGENT
K900259 · Medical Analysis Systems, Inc. · Feb 1990
TOTAL BILIRUBIN L.F.
K895822 · Sclavo, Inc. · Nov 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · Em Diagnostic Systems, Inc. · Oct 1989