Cleared Traditional

K905226 - TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL

K905226 is an FDA 510(k) clearance for TRIGLYCERIDE (GPO) REAGENT, manufactured by Enzyme Technology, Inc.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K905226 · Enzyme Technology, Inc. · Chemistry device
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Dec 1990
Decision
21d
Days
Class 1
Risk

K905226 is an FDA 510(k) clearance for the TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Enzyme Technology, Inc. (Shelton, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 21 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 Enzyme Technology, Inc. devices

FDA 510(k) Submission Details - K905226

510(k) Number K905226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date December 11, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K905226.
DNA TRIGLYCERIDE PROCEDURE
K941063 · Data Medical Associates, Inc. · Jul 1994
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO · Mar 1994
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
K914033 · Cholestech Corp. · Sep 1991
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · Data Medical Associates, Inc. · Jul 1990
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · Sigma Diagnostics, Inc. · Sep 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · Heraeus Kulzer, Inc. · Feb 1989