# K013126: N LP (a) Standard SY

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 9, 2001 after 51 days
- Product code: JIS (Calibrator, Primary)
- 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: 1 generation back to K000121 (2000). 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)
- K000121: Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a) Lpa Reagent, Lipoprotein (a) Calib, Beckman Coulter, Inc. (2000) Summary page 1.

## Indications for use
Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

Source page: https://510kreport.com/device/K013126
Methodology: https://510kreport.com/methodology