Cleared Traditional

LUQUIZYME TRIGLYCERIDE REAGENT SET (K803297) - FDA 510(k) Clearance

Class I Chemistry device.

K803297 · Amresco, Inc. · Chemistry device
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Jan 1981
Decision
17d
Days
Class 1
Risk

K803297 is an FDA 510(k) clearance for the LUQUIZYME TRIGLYCERIDE REAGENT SET. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 17 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 Amresco, Inc. devices

Submission Details

510(k) Number K803297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date January 16, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 37
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K803297.
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · Em Diagnostic Systems, Inc. · May 1984
REAGENT SET TRIGLYCERIDES GPO
K833082 · Boehringer Mannheim Corp. · Nov 1983
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029 · Eastman Kodak Company · Aug 1981
DELTA TEST TRIGLYCERIDES
K802136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · Sigma Chemical Co. · Mar 1980
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234 · Boehringer Mannheim Corp. · Nov 1979