Cleared Traditional

A-GENT TRIGLLYCERIDES GPO (K874187) - FDA 510(k) Clearance

Class I Chemistry device.

K874187 · Abbott Laboratories · Chemistry device
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Jan 1988
Decision
99d
Days
Class 1
Risk

K874187 is an FDA 510(k) clearance for the A-GENT TRIGLLYCERIDES GPO. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 21, 1988 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K874187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date January 21, 1988
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
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 54
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K874187.
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
TRIGLYERIDES TEST KIT
K874584 · Ciba Corning Diagnostics Corp. · Jan 1988
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · Boehringer Mannheim Corp. · Aug 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · Em Diagnostic Systems, Inc. · Mar 1987