# K981354: Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 1, 1998 after 17 days
- Product code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P820060 (1983). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820060: Abbott Afp-Eia Diagnostic Kit for Cancer, Abbott Laboratories (1983) Summary page 1.

## Most influential descendants
- 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
- 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
- K090236: Dimension Vista Afp Flex Reagent Cartridge, Model 6454 (2009), 0 descendants of its own

## Recalls of this device
- Jul 18, 2005 · Not classified · Z-1388-05: Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.

## Indications for use
The ACCESS® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination-of alpha-fetoprotein (AFP) in human serum using the ACCESS Immunoassay System. AFP measured by the ACCESS AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.

Source page: https://510kreport.com/device/K981354
Methodology: https://510kreport.com/methodology