Cleared Traditional

K803091 - TRIGLYCERIDES (UV)-2 REAGENTS

K803091 is the FDA 510(k) clearance for TRIGLYCERIDES (UV)-2 REAGENTS by Reagents Applications, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K803091 · Reagents Applications, Inc. · Chemistry device
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Jan 1981
Decision
32d
Days
Class 1
Risk

K803091 is an FDA 510(k) clearance for the TRIGLYCERIDES (UV)-2 REAGENTS. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 32 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K803091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date January 09, 1981
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K803091.
DATA-ZYME TRIGLYCERIDE
K810965 · Data Medical Associates, Inc. · Apr 1981
ENZYMATIC TRIGLYCERIDE
K810680 · Pointe Scientific, Inc., · Mar 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297 · Amresco, Inc. · Jan 1981
DELTA TEST TRIGLYCERIDES
K802136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226 · Reagents Applications, Inc. · Jun 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · Reagents Applications, Inc. · May 1980