# K232904: Access Ostase

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter
- Decided: Apr 15, 2024 after 210 days
- Product code: CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930810 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994278: Access Ostase Immunoenzymetric Assay, Beckman Coulter, Inc. (2000) Summary page 4.

## Indications for use
The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

Source page: https://510kreport.com/device/K232904
Methodology: https://510kreport.com/methodology