Cleared Traditional

K014032 - OLYMPUS LDL CHOLESTEROL REAGENT

K014032 is the FDA 510(k) clearance for OLYMPUS LDL CHOLESTEROL REAGENT by Olympus America, Inc.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K014032 · Olympus America, Inc. · Chemistry device
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Feb 2002
Decision
64d
Days
Class 1
Risk

K014032 is an FDA 510(k) clearance for the OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS .... Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K014032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2001
Decision Date February 08, 2002
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 48
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K014032.
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · Stanbio Laboratory · Mar 2004
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp. · Aug 2001
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · Kamiya Biomedical Co. · Jun 1999
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998