# K981864: Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 12, 1998 after 16 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K891475 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891475: Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3, Bio-Rad (1989) Summary page 1.

## Most influential descendants
- K994277: Access Ostase QC (2000), 0 descendants of its own

## Recalls of this device
- Apr 21, 2010 · Not classified · Z-2208-2010: The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulte

## Indications for use
The ACCESS® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the ACCESS Immunoassay System.

Source page: https://510kreport.com/device/K981864
Methodology: https://510kreport.com/methodology