Cleared Traditional

K080435 - OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

K080435 is an FDA 510(k) clearance for OLYMPUS DIRECT BILIRUBIN REAGENT, manufactured by Olympus Life Science Research Europa GmbH (Europa). The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K080435 · Olympus Life Science Research Europa GmbH (Europa) · Chemistry device
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Sep 2008
Decision
199d
Days
Class 2
Risk

K080435 is an FDA 510(k) clearance for the OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Olympus Life Science Research Europa GmbH (Europa) (Center Valley, US). The FDA issued a Cleared decision on September 5, 2008 after a review of 199 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. 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.

FDA 510(k) Submission Details - K080435

510(k) Number K080435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date September 05, 2008
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 88d · This submission: 199d
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 222
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K080435.
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · Roche Diagnostics · Jan 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
COBAS INTEGRA C 111
K063744 · Rochdiag · Jan 2007
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
K063543 · Roche Diagnostics Corp. · Dec 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · Nova Biomedical Corp. · Nov 2006
K080435 · OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
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