Cleared Traditional

K941063 - DNA TRIGLYCERIDE PROCEDURE

K941063 is the FDA 510(k) clearance for DNA TRIGLYCERIDE PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code JGY) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K941063 · Data Medical Associates, Inc. · Chemistry device
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Jul 1994
Decision
134d
Days
Class 1
Risk

K941063 is an FDA 510(k) clearance for the DNA TRIGLYCERIDE PROCEDURE. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 134 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K941063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date July 20, 1994
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGY Colorimetric Method, 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 - JGY Colorimetric Method, Triglycerides

All 10
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K941063.
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO · Mar 1994
DMA TRIGLYCERIDE (GPO) PROCEDURE
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K894063 · Sigma Diagnostics, Inc. · Sep 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · Heraeus Kulzer, Inc. · Feb 1989
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · Trace Scientific , Ltd. · Apr 1986
TRIGLYZYME V EIKEN
K821106 · Syn-Kit, Inc. · May 1982