Cleared Traditional

K873117 - BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT

K873117 is the FDA 510(k) clearance for BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (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.

View all Biotrol, USA, Inc. devices

Submission Details

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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 196
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K873117.
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
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
FAST GLUCOSE
K870631 · Sclavo, Inc. · Mar 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · Lifescan, Inc. · Feb 1987