Cleared Traditional

K850031 - VISION TRIGLYCERIDES

K850031 is an FDA 510(k) clearance for VISION TRIGLYCERIDES, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850031 · Abbott Laboratories · Chemistry device
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Feb 1985
Decision
28d
Days
Class 1
Risk

K850031 is an FDA 510(k) clearance for the VISION TRIGLYCERIDES. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 4, 1985 after a review of 28 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K850031

510(k) Number K850031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date February 04, 1985
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 119
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K850031.
TGL REAGENT
K852010 · Alpkem Corp. · May 1985
TRIGLYCERIDE(TRINDER) PROCEDURE
K851538 · Data Medical Associates, Inc. · May 1985
PERIDOCHROM TRIGLYCERIDES GPO
K850667 · Boehringer Mannheim Corp. · Mar 1985
TRIGLYCERIDE REAGENT
K844032 · Sigma Diagnostics, Inc. · Nov 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984
TRIGLYCERIDES GPO REAGENT
K843552 · Bio-Rad · Sep 1984