Cleared Traditional

K873128 - GLUCOSE REAGENT KIT

K873128 is an FDA 510(k) clearance for GLUCOSE REAGENT KIT, manufactured by A-Kem, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K873128 · A-Kem, Inc. · Chemistry device
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Oct 1987
Decision
74d
Days
Class 2
Risk

K873128 is an FDA 510(k) clearance for the GLUCOSE REAGENT KIT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 74 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 A-Kem, Inc. devices

FDA 510(k) Submission Details - K873128

510(k) Number K873128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date October 23, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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 314
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K873128.
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · Home Diagnostics, Inc. · Oct 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · Biochemical Trade, Inc. · May 1987