Cleared Traditional

K981632 - ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

K981632 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS, manufactured by Roche Diagnostics/Boehringer Mannheim GmbH. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K981632 · Roche Diagnostics/Boehringer Mannheim GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
38d
Days
Class 2
Risk

K981632 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Roche Diagnostics/Boehringer Mannheim GmbH (Indianapolis, US). The FDA issued a Cleared decision on June 15, 1998 after a review of 38 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 Diagnostics/Boehringer Mannheim GmbH devices

FDA 510(k) Submission Details - K981632

510(k) Number K981632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date June 15, 1998
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K981632.
DBIL
K981943 · Abbott Laboratories · Jul 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
K981883 · Boehringer Mannheim Corp. · Jul 1998
CARESIDE TOTAL BILIRUBIN
K981588 · Careside, Inc. · Jun 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · Diagnostic Chemicals , Ltd. · Jun 1998
N-ASSAY L D-BIL
K981276 · Crestat Diagnostics, Inc. · May 1998
TBIL
K981336 · Abbott Laboratories · May 1998