# K013359: LP (a)-Latex Seiken Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken'S
- Decided: Mar 8, 2002 after 149 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 K982708 (1999). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982708: SPQ Test System, DiaSorin, Inc. (1999) Summary page 1.

## Most influential descendants
- K082488: Diazyme LP (a) Assay (2009), 3 descendants of its own
- K122722: Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2 Califrator Set Model 05852641160 (2012), 1 descendant of its own
- K241220: Tina-quant Lipoprotein (a) Gen.2 Molarity (2025), 0 descendants of its own
- K131556: Diazyme Lipoprotein (a) Calibrator Set, Control Set (2013), 0 descendants of its own

## Indications for use
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

Source page: https://510kreport.com/device/K013359
Methodology: https://510kreport.com/methodology