Cleared Traditional

K801012 - TRIGLYCERIDE REAGENT (COLOR)

K801012 is the FDA 510(k) clearance for TRIGLYCERIDE REAGENT (COLOR) by Gilford Diagnostics. It is a Class 1 Chemistry device (product code JGY) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801012 · Gilford Diagnostics · Chemistry device
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May 1980
Decision
16d
Days
Class 1
Risk

K801012 is an FDA 510(k) clearance for the TRIGLYCERIDE REAGENT (COLOR). Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 16 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 Gilford Diagnostics devices

Submission Details

510(k) Number K801012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date May 14, 1980
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 K801012.
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
TRIGLYCERIDES TEST (500NM)
K800551 · Reagents Applications, Inc. · Mar 1980
ELVI TRIGLYCERIDE
K792414 · Volu Sol Medical Industries · Dec 1979
TRI-CON TRIGLYCERIDGE REAGENTS
K761283 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1977