# K013130: N LP (a) Control SY

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 18, 2001 after 29 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K992665 (1999). 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)
- K992665: Macra LP (a) Enzyme Immunoassay Kit, Trinity Biotech USA (1999) Summary page 1.

## Indications for use
The N Lp(a) Control SY is an assayed control for accuracy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

Source page: https://510kreport.com/device/K013130
Methodology: https://510kreport.com/methodology