OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024— 510(k) K040471

Clearance details

Applicant

Olympus America, Inc.

Product code

Code JIT

Device class

Class 2

Regulation

21 CFR 862.1150

Advisory panel

Clinical Chemistry

Date received

2004-02-24

Decision date

2004-03-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Irving, TX, US

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• Z-1135-2026 — The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.Class II·Ongoing·Beckman Coulter Ireland, Inc.·20251208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040471.