Cleared Traditional

K871586 - GLUCOCHEK S.C. WITH AUDIO OPTION

K871586 is an FDA 510(k) clearance for GLUCOCHEK S.C. WITH AUDIO OPTION, manufactured by Larken Industries, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K871586

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.

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 307
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K871586.
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
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · Home Diagnostics, Inc. · Oct 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · Biochemical Trade, Inc. · May 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987