Cleared Traditional

K960088 - TRUE TRIGLYCERIDE

K960088 is an FDA 510(k) clearance for TRUE TRIGLYCERIDE, manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K960088 · Diagnostic Chemicals , Ltd. · Chemistry device
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Apr 1996
Decision
81d
Days
Class 1
Risk

K960088 is an FDA 510(k) clearance for the TRUE TRIGLYCERIDE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on April 1, 1996 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Chemicals , Ltd. devices

FDA 510(k) Submission Details - K960088

510(k) Number K960088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date April 01, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

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 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K960088.
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K953971 · Trace America, Inc. · Apr 1996
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K952741 · Medical Diagnostic Technologies, Inc. · Aug 1995
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K931891 · Em Diagnostic Systems, Inc. · Aug 1993