Cleared Traditional

TRIGLYCERIDES TEST KIT (K895952) - FDA 510(k) Clearance

Class I Chemistry device.

K895952 · Elite Technology, Inc. · Chemistry device
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Jan 1990
Decision
92d
Days
Class 1
Risk

K895952 is an FDA 510(k) clearance for the TRIGLYCERIDES TEST KIT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on January 11, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 Elite Technology, Inc. devices

Submission Details

510(k) Number K895952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date January 11, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, 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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 37
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K895952.
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · Em Diagnostic Systems, Inc. · Nov 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · Em Diagnostic Systems, Inc. · Mar 1991
COBAS READY TRIGLYCERIDE REAGENT
K896231 · Roche Diagnostic Systems, Inc. · Feb 1990
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · Em Diagnostic Systems, Inc. · Aug 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · Roche Diagnostic Systems, Inc. · Aug 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · Em Diagnostic Systems, Inc. · Feb 1989