Cleared Traditional

K903897 - TRIGLYCERIDES REAGENT GPO 5 X CONC.

K903897 is the FDA 510(k) clearance for TRIGLYCERIDES REAGENT GPO 5 X CONC. by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K903897 · Trace Scientific , Ltd. · Chemistry device
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Oct 1990
Decision
39d
Days
Class 1
Risk

K903897 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT GPO 5 X CONC.. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Australia 3168, AU). The FDA issued a Cleared decision on October 1, 1990 after a review of 39 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K903897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1990
Decision Date October 01, 1990
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, 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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 112
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