Cleared Traditional

BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT (K864939) - FDA 510(k) Clearance

Class I Chemistry device.

K864939 · Beckman Instruments, Inc. · Chemistry device
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Dec 1986
Decision
15d
Days
Class 1
Risk

K864939 is an FDA 510(k) clearance for the BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 31, 1986 after a review of 15 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K864939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1986
Decision Date December 31, 1986
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 47
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K864939.
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · Boehringer Mannheim Corp. · Aug 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · Em Diagnostic Systems, Inc. · Mar 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · Sigma Diagnostics, Inc. · Feb 1987
IQ TRIGLYCERIDES
K864268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · Em Diagnostic Systems, Inc. · Aug 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · Boehringer Mannheim Corp. · Jun 1986