Cleared Traditional

K871301 - ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD

K871301 is an FDA 510(k) clearance for ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K871301 · American Monitor Corp. · Chemistry device
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Apr 1987
Decision
21d
Days
Class 1
Risk

K871301 is an FDA 510(k) clearance for the ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 22, 1987 after a review of 21 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 American Monitor Corp. devices

FDA 510(k) Submission Details - K871301

510(k) Number K871301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date April 22, 1987
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

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 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K871301.
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · Boehringer Mannheim Corp. · Aug 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · Trace Scientific , Ltd. · May 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · Trace Scientific , Ltd. · May 1987
TRIGLYCERIDES DETERMINATION
K871122 · Biochemical Trade, Inc. · Apr 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · Intersect Systems, Inc. · Mar 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · Em Diagnostic Systems, Inc. · Mar 1987