Cleared Traditional

IL TEST(TM) TRIGLYCERIDE (K931116) - FDA 510(k) Clearance

Class I Toxicology device.

K931116 · Instrumentation Laboratory CO · Toxicology device
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Mar 1994
Decision
389d
Days
Class 1
Risk

K931116 is an FDA 510(k) clearance for the IL TEST(TM) TRIGLYCERIDE. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1705 - the FDA toxicology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K931116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date March 28, 1994
Days to Decision 389 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 87d · This submission: 389d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGY Colorimetric Method, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.