Cleared Traditional

K111516 - NMR LIPOPROFILE (R) TEST AND NMR PROFILER

K111516 is an FDA 510(k) clearance for NMR LIPOPROFILE TEST AND NMR PROFILER, manufactured by Liposcience, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K111516 · Liposcience, Inc. · Chemistry device
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Sep 2011
Decision
118d
Days
Class 1
Risk

K111516 is an FDA 510(k) clearance for the NMR LIPOPROFILE (R) TEST AND NMR PROFILER. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Liposcience, Inc. (Raleigh, US). The FDA issued a Cleared decision on September 27, 2011 after a review of 118 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 Liposcience, Inc. devices

FDA 510(k) Submission Details - K111516

510(k) Number K111516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date September 27, 2011
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

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 65
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K111516.
Direct HDL Cholesterol (HDL)
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POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
K100550 · Polymedco, Inc. · Sep 2010
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