Cleared Special

K092603 - COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

K092603 is an FDA 510(k) clearance for COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CFR cleared through the Special 510(k) pathway after a 101-day FDA review.

K092603 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
101d
Days
Class 2
Risk

K092603 is an FDA 510(k) clearance for the COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 4, 2009 after a review of 101 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K092603

510(k) Number K092603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2009
Decision Date December 04, 2009
Days to Decision 101 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K092603.
PRESTIGE 24I
K103531 · Tokyo Boeki Medisys, Inc. · Dec 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788 · HORIBA ABX SAS · Nov 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · Siemens Healthcare Diagnostics · Mar 2011
POLY-CHEM 90 GLUCOSE
K090703 · Polymedco, Inc. · Oct 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · Horiba Abx · Sep 2008
K092603 · COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
Download PDF FDA Summary Roche Diagnostics