Cleared Traditional

K850364 - GLUCOSE - TRINDER- REAGENT

K850364 is an FDA 510(k) clearance for GLUCOSE - TRINDER- REAGENT, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K850364 · Sigma Chemical Co. · Chemistry device
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Mar 1985
Decision
34d
Days
Class 2
Risk

K850364 is an FDA 510(k) clearance for the GLUCOSE - TRINDER- REAGENT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 34 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.

FDA 510(k) Submission Details - K850364

510(k) Number K850364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date March 05, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 89d · This submission: 34d
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 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K850364.
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc. · Jun 1985
GLU(GOD) REAGENT
K851992 · Alpkem Corp. · May 1985
BCS GLUCOSE COLORIMETRIC TEST
K850257 · Bioclinical Systems, Inc. · Mar 1985
GLUCOSE AUTO& STAT GA-1120
K843003 · Kyoto Diagnostics, Inc. · Sep 1984
GLUCOSE OXIDASE ENZYMATIC REAGENT SET
K843528 · Livonia Diagnostics, Inc. · Sep 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
K850364 · GLUCOSE - TRINDER- REAGENT
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