# K053612: Dri-Stat Acid Phosphatase Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 26, 2006 after 120 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
Longest line of descent: 1 generation back to K821674 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821674: Spinchem Acid Phosphatase Reagent, Smithkline Diagnostics, Inc. (1982) Summary page 1.

## Indications for use
Dri-STAT' Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

Source page: https://510kreport.com/device/K053612
Methodology: https://510kreport.com/methodology