# P820060: Abbott Afp-Eia Diagnostic Kit for Cancer

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Jun 21, 1983 after 312 days
- Product code: LOK (Kit, Test, Alpha-Fetoprotein For Neural Tube Defects)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- 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; 4 cite 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
- K981354: Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 (1998), 3 descendants of its own
- K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600 (2008), 2 descendants of its own
- K983031: Vitros Immunodiagnostic Products Afp Assay (1998), 1 descendant of its own
- K213626: Vitros Afp (2022), 0 descendants of its own
- K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604 (2011), 0 descendants of its own

## Recalls of this device
- Sep 18, 2007 · Not classified · Z-0299-2008: The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that
- Mar 4, 2003 · Not classified · Z-0726-03: The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

Source page: https://510kreport.com/device/P820060
Methodology: https://510kreport.com/methodology