Cleared Traditional

K931402 - IL TEST GLUCOSE

K931402 is the FDA 510(k) clearance for IL TEST GLUCOSE by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K931402 · Instrumentation Laboratory CO · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
207d
Days
Class 2
Risk

K931402 is an FDA 510(k) clearance for the IL TEST GLUCOSE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 207 days - an extended review 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: 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.

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Submission Details

510(k) Number K931402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date October 12, 1993
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 93
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K931402.
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908 · Sigma Diagnostics, Inc. · May 1995
OLYMPUS GLUCOSE REAGENT
K944406 · Olympus America, Inc. · Mar 1995
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · Heraeus Kulzer, Inc. · Dec 1993
GLUCOSE-HK TEST
K931890 · Em Diagnostic Systems, Inc. · Jul 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361 · Heraeus Kulzer, Inc. · Jun 1993
ROCHE COBAS FUTURA GLUCOSE
K922811 · Roche Diagnostic Systems, Inc. · Jan 1993