Cleared Special

K062239 - GLUCOSE HK NEW FORMULATION TEST SYSTEM

K062239 is the FDA 510(k) clearance for GLUCOSE HK NEW FORMULATION TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CFR) cleared through the Special 510(k) pathway after a 40-day FDA review.

K062239 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
40d
Days
Class 2
Risk

K062239 is an FDA 510(k) clearance for the GLUCOSE HK NEW FORMULATION TEST SYSTEM. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 40 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K062239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date September 11, 2006
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 85
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K062239.
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
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · Roche Diagnostics Corp. · May 2006
GLUCOSE
K060383 · Abbott Laboratories · May 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256 · Beckman Coulter, Inc. · Feb 2006