# K023840: Acid Phosphatase Assay for the Advia 1650

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jan 7, 2003 after 50 days
- Product code: CKB (Acid Phosphatase, Naphthyl Phosphate)
- Device class: 2
- Regulation: 21 CFR 862.1020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030801: Bayer Advia 1650 Special Chemistry Control (2003), 3 descendants of its own
- K033379: Bayer Special Chemistry Controls (2003), 1 descendant of its own
- K030804: Bayer Advia 1650 Special Chemistry Calibrator (2003), 1 descendant of its own
- K061137: Advia Ims Cpsa Control (2006), 0 descendants of its own
- K033380: Bayer Special Chemistry Calibrators (2003), 0 descendants of its own

## Indications for use
The Buyer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic devke intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

Source page: https://510kreport.com/device/K023840
Methodology: https://510kreport.com/methodology