Cleared Traditional

K040974 - GLUCOSE OXIDASE, GLUCOSE

K040974 is an FDA 510(k) clearance for GLUCOSE OXIDASE, manufactured by Genchem, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K040974 · Genchem, Inc. · Chemistry device
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Dec 2004
Decision
257d
Days
Class 2
Risk

K040974 is an FDA 510(k) clearance for the GLUCOSE OXIDASE, GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004 after a review of 257 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Genchem, Inc. devices

FDA 510(k) Submission Details - K040974

510(k) Number K040974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date December 27, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 88d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 269
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K040974.
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285 · Infopia Co, Ltd. · Aug 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · Lifescan, Inc. · May 2005
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K043245 · Eps Bio Technology Corp. · Apr 2005
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427 · Arkray, Inc. · Nov 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · Diamond Diagnostics, Inc. · Jan 2004
RANDOX RX DAYTONA
K024014 · Randox Laboratories, Ltd. · Dec 2003