Cleared Traditional

TRIGLYCERIDES - GPO REAGENT (K890337) - FDA 510(k) Clearance

Class I Chemistry device.

K890337 · Alpkem Corp. · Chemistry device
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Mar 1989
Decision
45d
Days
Class 1
Risk

K890337 is an FDA 510(k) clearance for the TRIGLYCERIDES - GPO REAGENT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 45 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 Alpkem Corp. devices

Submission Details

510(k) Number K890337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date March 09, 1989
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 K890337.
COBAS READY TRIGLYCERIDE REAGENT
K896231 · Roche Diagnostic Systems, Inc. · Feb 1990
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · Em Diagnostic Systems, Inc. · Aug 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · Roche Diagnostic Systems, Inc. · Aug 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · Em Diagnostic Systems, Inc. · Feb 1989
A-GENT TRIGLLYCERIDES GPO
K874187 · Abbott Laboratories · Jan 1988
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · Boehringer Mannheim Corp. · Aug 1987