Cleared Traditional

K181373 - Extended Lipid Panel Assay (FDA 510(k) Clearance)

Class I Chemistry device.

K181373 · Laboratory Corporation of America Holdings · Chemistry device
Oct 2018
Decision
147d
Days
Class 1
Risk

K181373 is an FDA 510(k) clearance for the Extended Lipid Panel Assay. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Laboratory Corporation of America Holdings (Morrisville, US). The FDA issued a Cleared decision on October 18, 2018 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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.

Submission Details

510(k) Number K181373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2018
Decision Date October 18, 2018
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 234d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K181373.
Lipids
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