Cleared Traditional

K132711 - CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (FDA 510(k) Clearance)

Class I Chemistry device.

K132711 · Carolina Liquid Chemistries Corp. · Chemistry device
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May 2014
Decision
252d
Days
Class 1
Risk

K132711 is an FDA 510(k) clearance for the CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Carolina Liquid Chemistries Corp. (Winston-Salem, US). The FDA issued a Cleared decision on May 8, 2014 after a review of 252 days - an extended review 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: 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 Carolina Liquid Chemistries Corp. devices

Submission Details

510(k) Number K132711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2013
Decision Date May 08, 2014
Days to Decision 252 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
164d slower than avg
Panel avg: 88d · This submission: 252d
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.