Cleared Traditional

TRIGLYZYME V EIKEN (K821106) - FDA 510(k) Clearance

Class I Chemistry device.

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
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.