Cleared Traditional

K871586 - GLUCOCHEK S.C. WITH AUDIO OPTION

K871586 is the FDA 510(k) clearance for GLUCOCHEK S.C. WITH AUDIO OPTION by Larken Industries, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K871586 · Larken Industries, Inc. · Chemistry device
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Sep 1987
Decision
146d
Days
Class 2
Risk

K871586 is an FDA 510(k) clearance for the GLUCOCHEK S.C. WITH AUDIO OPTION. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Larken Industries, Inc. (Lenexa, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 146 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 Larken Industries, Inc. devices

Submission Details

510(k) Number K871586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1987
Decision Date September 16, 1987
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 88d · This submission: 146d
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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K871586.
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
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