Cleared Special

K092603 - COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

K092603 is the FDA 510(k) clearance for COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY by Roche Diagnostics. It is a Class 2 Chemistry device (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)
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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.

View all Roche Diagnostics devices

Submission Details

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.

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 100
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K092603.
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · Siemens Healthcare Diagnostics, Inc. · May 2012
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
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 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