Cleared Traditional

K854182 - IN-VITRO TEST DETERMINATION OF TRIALYCERIDE

K854182 is an FDA 510(k) clearance for IN-VITRO TEST DETERMINATION OF TRIALYCERIDE, manufactured by Clinical Data, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854182 · Clinical Data, Inc. · Chemistry device
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Nov 1985
Decision
41d
Days
Class 1
Risk

K854182 is an FDA 510(k) clearance for the IN-VITRO TEST DETERMINATION OF TRIALYCERIDE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 41 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K854182

510(k) Number K854182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 132
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K854182.
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · Catachem, Inc. · Mar 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · Sterling Diagnostics, Inc. · Feb 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783 · Sclavo, Inc. · Jan 1986
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · American Monitor Corp. · Nov 1985
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152 · Technicon Instruments Corp. · Nov 1985
TGL REAGENT
K852010 · Alpkem Corp. · May 1985