Cleared Traditional

Triglycerides (K150819) - FDA 510(k) Clearance

Class I Chemistry device.

K150819 · Randox Laboratories Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
132d
Days
Class 1
Risk

K150819 is an FDA 510(k) clearance for the Triglycerides. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on August 6, 2015 after a review of 132 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 Randox Laboratories Limited devices

Submission Details

510(k) Number K150819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2015
Decision Date August 06, 2015
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 50
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K150819.
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · Siemens Healthcare Diagnostics, Inc. · Nov 2013
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · Olympus America, Inc. · Mar 2007
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · Dade Behring, Inc. · Jan 2005
TGL FLEX REAGENT CARTRIDGE
K010871 · Dade Behring, Inc. · Jul 2001
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · Wako Chemicals USA, Inc. · Nov 1999
OLYMPUS LIPASE REAGENT
K963424 · Olympus America, Inc. · Jan 1997