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.

View all Olympus Life Science Research Europa GmbH (Europa) devices

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
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 216
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K080435.
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · Medica Corp. · Sep 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · Roche Diagnostics · Jan 2009
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
K080810 · Medica Corp. · Dec 2008
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
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · Dade Behring, Inc. · Aug 2006