# K013128: N Latex LP (a)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 18, 2002 after 121 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 K000121 (2000). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 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.

## Most influential descendants
- K030477: Diadexus Plac Test (2003), 4 descendants of its own
- K050029: Cardiompo Test (2005), 2 descendants of its own
- K050487: Quantia LA (a) (2005), 1 descendant of its own
- K141575: Plac Test for LP-PLA2 Activity (2014), 0 descendants of its own
- K132400: LP (a) Calibrators, and LP (a) Controls (2013), 0 descendants of its own

## Indications for use
N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma. N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.

Source page: https://510kreport.com/device/K013128
Methodology: https://510kreport.com/methodology