Cleared Traditional

K153435 - Direct HDL Cholesterol (HDL)

K153435 is the FDA 510(k) clearance for Direct HDL Cholesterol (HDL) by Randox Laboratories, Ltd.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K153435 · Randox Laboratories, Ltd. · Chemistry device
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Jan 2016
Decision
42d
Days
Class 1
Risk

K153435 is an FDA 510(k) clearance for the Direct HDL Cholesterol (HDL). Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 8, 2016 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K153435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2015
Decision Date January 08, 2016
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 47
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K153435.
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · Ortho-Clinical Diagnostics, Inc. · Sep 2012
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · Beckman Coulter, Inc. · May 2010
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · Wako Chemicals USA, Inc. · Jul 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · Medica Corp. · Apr 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395 · Diazyme Laboratories · Jan 2008
ENVOY 500 HDL
K071706 · Clinical Data, Inc. · Dec 2007