Cleared Traditional

K843003 - GLUCOSE AUTO& STAT GA-1120

K843003 is the FDA 510(k) clearance for GLUCOSE AUTO& STAT GA-1120 by Kyoto Diagnostics, Inc.. It is a Class 2 Toxicology device (product code CGA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K843003 · Kyoto Diagnostics, Inc. · Toxicology device
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Sep 1984
Decision
60d
Days
Class 2
Risk

K843003 is an FDA 510(k) clearance for the GLUCOSE AUTO& STAT GA-1120. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Kyoto Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1345 - the FDA toxicology device 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 Kyoto Diagnostics, Inc. devices

Submission Details

510(k) Number K843003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date September 28, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 87d · This submission: 60d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K843003.
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc. · Jun 1985
GLU(GOD) REAGENT
K851992 · Alpkem Corp. · May 1985
GLUCOSE - TRINDER- REAGENT
K850364 · Sigma Chemical Co. · Mar 1985
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
SYSTEMATE GLUCOSE 67215
K843151 · Em Diagnostic Systems, Inc. · Aug 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984