Cleared Traditional

K864231 - U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE...

K864231 is the FDA 510(k) clearance for U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE... by U. S. Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K864231 · U. S. Diagnostics, Inc. · Chemistry device
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Dec 1986
Decision
37d
Days
Class 1
Risk

K864231 is an FDA 510(k) clearance for the U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 37 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 U. S. Diagnostics, Inc. devices

Submission Details

510(k) Number K864231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date December 04, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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 115
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K864231.
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · Sigma Diagnostics, Inc. · Feb 1987
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939 · Beckman Instruments, Inc. · Dec 1986
IQ TRIGLYCERIDES
K864268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
TRIGLYCERIDES
K863923 · Tech-Co, Inc. · Nov 1986
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
K863874 · Electro-Nucleonics Laboratories, Inc. · Nov 1986
TRIGLYCERIDES-E
K863075 · J. D. Assoc. · Sep 1986