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K Number
K063838
Device Name
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
Manufacturer
THERMO ELECTRON OY
Date Cleared
2007-09-27

(275 days)

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

For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments.

Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases

Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA to Thermo Electron Oy for their Lipoprotein(a) test system. This document grants market clearance for the device but does not contain the detailed study information or acceptance criteria requested.

Therefore, I cannot extract the specific information required to answer your questions about acceptance criteria, device performance, study details (sample sizes, provenance, expert qualifications, adjudication, MRMC, standalone), or ground truth establishment. This type of information is typically found within the actual 510(k) submission document, which is not provided here.

§ 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).