Cleared Traditional

K811165 - GLUCOSE OXIDASE RATE REAGENT

K811165 is the FDA 510(k) clearance for GLUCOSE OXIDASE RATE REAGENT by Chem-Elec, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K811165 · Chem-Elec, Inc. · Chemistry device
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Aug 1981
Decision
107d
Days
Class 2
Risk

K811165 is an FDA 510(k) clearance for the GLUCOSE OXIDASE RATE REAGENT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 107 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. 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 Chem-Elec, Inc. devices

Submission Details

510(k) Number K811165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date August 13, 1981
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 198
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K811165.
ELECTROLYTE GEL
K813370 · Hi Chem, Inc. · Dec 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · American Research Products Co. · Dec 1981
ACR ENZYMATIC GLUCOSE OXIDASE
K812258 · Harleco · Aug 1981
KING DIAGNOSTICS GLUCOSE TEST
K811882 · King Diagnostics, Inc. · Jul 1981
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
K811592 · Amresco, Inc. · Jul 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392 · Miles Laboratories, Inc. · May 1981