Cleared Traditional

K181373 - Extended Lipid Panel Assay

K181373 is an FDA 510(k) clearance for Extended Lipid Panel Assay, manufactured by Laboratory Corporation of America Holdings. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K181373 · Laboratory Corporation of America Holdings · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Laboratory Corporation of America Holdings devices

FDA 510(k) Submission Details - K181373

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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

All 186
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