Cleared Traditional

HDL CHOLESTEROL (HDLX) ASSAY (K100010) - FDA 510(k) Clearance

Class I Chemistry device.

K100010 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
130d
Days
Class 1
Risk

K100010 is an FDA 510(k) clearance for the HDL CHOLESTEROL (HDLX) ASSAY. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 14, 2010 after a review of 130 days - within the typical 510(k) review window.

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: 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K100010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2010
Decision Date May 14, 2010
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K100010.
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · Dade Behring, Inc. · Dec 2005
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
HDL
K981580 · Abbott Laboratories · Jun 1998
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988