Cleared Special

K092506 - EASYRA GLU-H REAGENT, MODEL 10200

K092506 is an FDA 510(k) clearance for EASYRA GLU-H REAGENT, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code CFR cleared through the Special 510(k) pathway after a 30-day FDA review.

K092506 · Medica Corp. · Chemistry device
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Sep 2009
Decision
30d
Days
Class 2
Risk

K092506 is an FDA 510(k) clearance for the EASYRA GLU-H REAGENT, MODEL 10200. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on September 16, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 - K092506

510(k) Number K092506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2009
Decision Date September 16, 2009
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 141
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K092506.
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · Siemens Healthcare Diagnostics · Mar 2011
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · Roche Diagnostics · Dec 2009
POLY-CHEM 90 GLUCOSE
K090703 · Polymedco, Inc. · Oct 2009
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · Horiba Abx · Sep 2008
LIASYS WITH MODELS LIASYS
K080468 · Ams S.R.L. Analyzer Medical System · Jul 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008
K092506 · EASYRA GLU-H REAGENT, MODEL 10200
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