Cleared Traditional

K771001 - STATZYME GLUCOSE

K771001 is the FDA 510(k) clearance for STATZYME GLUCOSE by Worthington Biochemical Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K771001 · Worthington Biochemical Corp. · Chemistry device
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Jul 1977
Decision
38d
Days
Class 2
Risk

K771001 is an FDA 510(k) clearance for the STATZYME GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Worthington Biochemical Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Worthington Biochemical Corp. devices

Submission Details

510(k) Number K771001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1977
Decision Date July 11, 1977
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 205
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K771001.
MULTISTAT III GLUCOSE TEST
K771471 · Instrumentation Laboratory CO · Sep 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059 · J.T. Baker Chemical Co. · Jul 1977
TRENDAR
K771000 · Hi Chem, Inc. · Jul 1977
GLUCOSE TRINDER, ENZYMATIC
K770317 · Icn Pharmaceuticals, Inc. · Mar 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · Beckman Instruments, Inc. · Feb 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · Boehringer Mannheim Corp. · Feb 1977