Cleared Traditional

K873117 - BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT

K873117 is an FDA 510(k) clearance for BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT, manufactured by Biotrol, USA, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K873117 · Biotrol, USA, Inc. · Chemistry device
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Aug 1987
Decision
21d
Days
Class 2
Risk

K873117 is an FDA 510(k) clearance for the BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Berwyn, US). The FDA issued a Cleared decision on August 31, 1987 after a review of 21 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 - K873117

510(k) Number K873117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date August 31, 1987
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 K873117.
GLUCOSE REAGENT KIT
K873128 · A-Kem, Inc. · Oct 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · Home Diagnostics, Inc. · Oct 1987
GLUCOCHEK S.C. WITH AUDIO OPTION
K871586 · Larken Industries, Inc. · Sep 1987
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION
K872049 · Garid, Inc. · Aug 1987
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
K864282 · Medical Device Consultants, Inc. · May 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · Biochemical Trade, Inc. · May 1987
K873117 · BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
Download PDF Biotrol, USA, Inc.