# K000121: Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a) Lpa Reagent, Lipoprotein (a) Calib

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 17, 2000 after 120 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013128: N Latex LP (a) (2002), 7 descendants of its own
- 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

Source page: https://510kreport.com/device/K000121
Methodology: https://510kreport.com/methodology