# K063838: Lipoprotein (a), Lipoprotein (a) Calibrator, Lipoprotein (a) Control, Control High

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Sep 27, 2007 after 275 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Li-heparin 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.

Source page: https://510kreport.com/device/K063838
Methodology: https://510kreport.com/methodology