Cleared Traditional

K875211 - GLUCOSE (TRINDER) CAT. # 220-32

K875211 is the FDA 510(k) clearance for GLUCOSE (TRINDER) CAT. # 220-32 by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K875211 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Apr 1988
Decision
122d
Days
Class 2
Risk

K875211 is an FDA 510(k) clearance for the GLUCOSE (TRINDER) CAT. # 220-32. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K875211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date April 18, 1988
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
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 192
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K875211.
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · American Research Products Co. · Jan 1989
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · Boehringer Mannheim Corp. · Dec 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987