# K011568: Randox Lipoprotein

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 28, 2001 after 130 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123046: Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) Calibrator (2012), 0 descendants of its own

## Recalls of this device
- Dec 20, 2024 · Class II · Z-1017-2025: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Dec 20, 2024 · Class II · Z-1018-2025: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

## Indications for use
The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic réagent for the quantitative determination of Lipoprotein (a) in serum and plasma. The method is an immunoturbidimetric assay in which aggiutination occurs dué to an antigen-antibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample. Lp(a) determination is intended for use in conjunction with ciinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations. This Application Sheet has been developed for the Hitachi 717 analyser and miust be used by suitably qualified laboratory personnel under appropriate laboratory conditions

Source page: https://510kreport.com/device/K011568
Methodology: https://510kreport.com/methodology