# K122722: Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2 Califrator Set Model 05852641160

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Nov 29, 2012 after 85 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: 3 generations back to K982708 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013359: LP (a)-Latex Seiken Assay Kit, Denka Seiken'S (2002) Summary page 5.
- K082488: Diazyme LP (a) Assay, General Atomics (2009) Summary page 4.

## Most influential descendants
- K241220: Tina-quant Lipoprotein (a) Gen.2 Molarity (2025), 0 descendants of its own

## Indications for use
The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. The Preciontrol Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Source page: https://510kreport.com/device/K122722
Methodology: https://510kreport.com/methodology