# K082488: Diazyme LP (a) Assay

- Pathway: 510(k) (Traditional)
- Applicant: General Atomics
- Decided: Jan 13, 2009 after 138 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: 2 generations back to K982708 (1999). 2 ancestors in all.
3 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)
- K013359: LP (a)-Latex Seiken Assay Kit, Denka Seiken'S (2002) Summary page 2.

## Most influential descendants
- 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 Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid-metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry. Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.

Source page: https://510kreport.com/device/K082488
Methodology: https://510kreport.com/methodology