# K123046: Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 20, 2012 after 83 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
Longest line of descent: 1 generation back to K011568 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011568: Randox Lipoprotein, Randox Laboratories, Ltd. (2001) Summary page 2.

## Indications for use
For in vitro diagnostic use in th 'e quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests. The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the calibration of AD VIA® Chemistry systems for the AD VIA Chemistry Lipoprotein(a) (LPA) assay.

Source page: https://510kreport.com/device/K123046
Methodology: https://510kreport.com/methodology