Cleared Traditional

K813412 - GLUCOSE ENZYME-COLOR REAGENT SET

K813412 is an FDA 510(k) clearance for GLUCOSE ENZYME-COLOR REAGENT SET, manufactured by Diagnostic Specialties. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K813412 · Diagnostic Specialties · Chemistry device
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Dec 1981
Decision
27d
Days
Class 2
Risk

K813412 is an FDA 510(k) clearance for the GLUCOSE ENZYME-COLOR REAGENT SET. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Specialties (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 27 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 Diagnostic Specialties devices

FDA 510(k) Submission Details - K813412

510(k) Number K813412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1981
Decision Date December 31, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K813412.
ACCUCHEK BG.
K821091 · Biodynamics Corp. · May 1982
VISIDEX REAGENT STRIPS
K821179 · Miles Laboratories, Inc. · May 1982
CHEMSTRIP UG
K820465 · Biodynamics Corp. · Mar 1982
ELECTROLYTE GEL
K813370 · Hi Chem, Inc. · Dec 1981
ASTRA REAGENT CONCENTRATE SYSTEM
K812866 · Nobel Scientific Industries, Inc. · Dec 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · American Research Products Co. · Dec 1981