Cleared Special

K091991 - EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200

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

K091991 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K091991

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 222
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K091991.
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
K110780 · Elitechgroup · Oct 2011
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
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
K091991 · EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
Download PDF Medica Corp.