# P980041: Access Afp Immunoassay System

- Pathway: PMA
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 8, 1999 after 115 days
- Product code: LOK (Kit, Test, Alpha-Fetoprotein For Neural Tube Defects)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100 (2003), 6 descendants of its own
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own
- K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (2019), 0 descendants of its own

Source page: https://510kreport.com/device/P980041
Methodology: https://510kreport.com/methodology