# K211058: Lp (a) Ultra

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Dec 22, 2022 after 622 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 K180074 (2018). 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)
- K180074: Diazyme Lipoprotein (a) Assay, Diazyme Laboratories, Inc. (2018) Summary page 4.

## Indications for use
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated 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. For In Vitro Diagnostic use.

Source page: https://510kreport.com/device/K211058
Methodology: https://510kreport.com/methodology