Cleared Traditional

K855164 - ENZYNATIC TRIGLYCERIDES REAGENT SET

K855164 is the FDA 510(k) clearance for ENZYNATIC TRIGLYCERIDES REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K855164 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
55d
Days
Class 1
Risk

K855164 is an FDA 510(k) clearance for the ENZYNATIC TRIGLYCERIDES REAGENT SET. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 55 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K855164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 19, 1986
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 112
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K855164.
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · Boehringer Mannheim Corp. · Jun 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
K860730 · Trace Scientific , Ltd. · Apr 1986
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
K860690 · Catachem, Inc. · Mar 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783 · Sclavo, Inc. · Jan 1986
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · Clinical Data, Inc. · Nov 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · American Monitor Corp. · Nov 1985