Cleared Traditional

IQ TRIGLYCERIDES (K864268) - FDA 510(k) Clearance

Class I Chemistry device.

K864268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Dec 1986
Decision
48d
Days
Class 1
Risk

K864268 is an FDA 510(k) clearance for the IQ TRIGLYCERIDES. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 48 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K864268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date December 16, 1986
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K864268.
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EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · Em Diagnostic Systems, Inc. · Aug 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · Boehringer Mannheim Corp. · Jun 1986
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152 · Technicon Instruments Corp. · Nov 1985