Cleared Special

K092506 - EASYRA GLU-H REAGENT

K092506 is the FDA 510(k) clearance for EASYRA GLU-H REAGENT by Medica Corp.. It is a Class 2 Chemistry device (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.

View all Medica Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 86
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K092506.
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2012
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
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008
POINTE 360
K062118 · Pointe Scientific, Inc., · Jul 2007