Cleared Special

K081193 - COBAS INTEGRA 400/800 BILIRUBIN TOTAL

K081193 is an FDA 510(k) clearance for COBAS INTEGRA 400/800 BILIRUBIN TOTAL, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CIG cleared through the Special 510(k) pathway after a 263-day FDA review.

K081193 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
263d
Days
Class 2
Risk

K081193 is an FDA 510(k) clearance for the COBAS INTEGRA 400/800 BILIRUBIN TOTAL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 263 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081193

510(k) Number K081193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date January 16, 2009
Days to Decision 263 days
Submission Type Special
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
174d slower than avg
Panel avg: 89d · This submission: 263d
Pathway characteristics
Modification to existing cleared device.

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 232
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K081193.
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · Polymedco, Inc. · Sep 2011
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
K093623 · Instrumentation Laboratory CO · Jun 2010
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · Medica Corp. · Sep 2009
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
K082210 · Genzyme Diagnostics P.E.I., Inc. · Dec 2008
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
K080810 · Medica Corp. · Dec 2008
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
K080435 · Olympus Life Science Research Europa GmbH (Europa) · Sep 2008
K081193 · COBAS INTEGRA 400/800 BILIRUBIN TOTAL
Download PDF FDA Summary Roche Diagnostics