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K Number
K023853
Device Name
K-ASSAY LP(A) CONTROLS
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2002-12-13

(24 days)

Product Code
DFC
Regulation Number
866.5600
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.

Device Description

Not Found

AI/ML Overview

While the provided text describes the FDA's decision regarding the K-ASSAY® Lp(a) Controls device, it does not contain any information about acceptance criteria, study details, or performance data. The document is a 510(k) clearance letter (K023853), which states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information. The text focuses on regulatory approval rather than the technical details of the device's performance study.

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).