Cleared Traditional

K931116 - IL TEST(TM) TRIGLYCERIDE

K931116 is the FDA 510(k) clearance for IL TEST(TM) TRIGLYCERIDE by Instrumentation Laboratory CO. It is a Class 1 Toxicology device (product code JGY) cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K931116 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - JGY Colorimetric Method, Triglycerides

All 7
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K931116.
DNA TRIGLYCERIDE PROCEDURE
K941063 · Data Medical Associates, Inc. · Jul 1994
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · Data Medical Associates, Inc. · Jul 1990
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · Sigma Diagnostics, Inc. · Sep 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · Heraeus Kulzer, Inc. · Feb 1989
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · Trace Scientific , Ltd. · Apr 1986
TRIGLYCERIDES TEST (500NM)
K800551 · Reagents Applications, Inc. · Mar 1980