Cleared Special

K091991 - EASY RA D BIL REAGENT MODEL 10212

K091991 is the FDA 510(k) clearance for EASY RA D BIL REAGENT MODEL 10212 by Medica Corp.. It is a Class 2 Chemistry device (product code CIG) cleared through the Special 510(k) pathway after a 64-day FDA review.

K091991 · Medica Corp. · Chemistry device
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Sep 2009
Decision
64d
Days
Class 2
Risk

K091991 is an FDA 510(k) clearance for the EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 64 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medica Corp. devices

Submission Details

510(k) Number K091991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2009
Decision Date September 04, 2009
Days to Decision 64 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 124
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K091991.
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · Roche Diagnostics · Feb 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · Abbott Laboratories · Feb 2013
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
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · Roche Diagnostics · Jan 2009
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