Cleared Special

EASYRA GLU-H REAGENT, MODEL 10200 (K092506) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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 144
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K092506.
Glucose HK Gen.3
K253490 · Roche Diagnostics · Feb 2026
Glucose2
K252357 · Abbott Ireland · Oct 2025
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics · Sep 2022
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899 · Roche Diagnostics · Aug 2019