Cleared Traditional

K871650 - GLUCOSE ENZYME - COLOR REAGENT SET

K871650 is an FDA 510(k) clearance for GLUCOSE ENZYME - COLOR REAGENT SET, manufactured by Biochemical Trade, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K871650 · Biochemical Trade, Inc. · Chemistry device
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May 1987
Decision
14d
Days
Class 2
Risk

K871650 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 Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 14 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 Biochemical Trade, Inc. devices

FDA 510(k) Submission Details - K871650

510(k) Number K871650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date May 12, 1987
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 303
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K871650.
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
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
FAST GLUCOSE
K870631 · Sclavo, Inc. · Mar 1987
GLUCOSE OXIDASE REAGENT
K870616 · Intersect Systems, Inc. · Mar 1987