Cleared Traditional

K821106 - TRIGLYZYME V EIKEN

K821106 is the FDA 510(k) clearance for TRIGLYZYME V EIKEN by Syn-Kit, Inc.. It is a Class 1 Chemistry device (product code JGY) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821106 · Syn-Kit, Inc. · Chemistry device
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May 1982
Decision
15d
Days
Class 1
Risk

K821106 is an FDA 510(k) clearance for the TRIGLYZYME V EIKEN. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 15 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K821106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 05, 1982
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K821106.
TRIGLYCERIDE (GPO) TRINDER REAGENT
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
TRIGLYCERIDE REAGENT (COLOR)
K801012 · Gilford Diagnostics · May 1980
TRIGLYCERIDES TEST (500NM)
K800551 · Reagents Applications, Inc. · Mar 1980
ELVI TRIGLYCERIDE
K792414 · Volu Sol Medical Industries · Dec 1979