# K132400: LP (a) Calibrators, and LP (a) Controls

- Pathway: 510(k) (Abbreviated)
- Applicant: Biokit, S.A.
- Decided: Dec 19, 2013 after 140 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K000121 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050487: Quantia LA (a), Biokit, S.A. (2005) Summary page 1.

## Indications for use
The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems. The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

Source page: https://510kreport.com/device/K132400
Methodology: https://510kreport.com/methodology