# K994278: Access Ostase Immunoenzymetric Assay

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 28, 2000 after 99 days
- Product code: CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930810 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961573: Tandem-R Ostase Immunoradiometric Assay, Hybritech, Inc. (1996) Summary page 1.

## Most influential descendants
- K232904: Access Ostase (2024), 0 descendants of its own

## Recalls of this device
- Oct 24, 2016 · Class II · Z-0407-2017: Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
- Oct 24, 2016 · Class II · Z-0408-2017: Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
- Nov 10, 2011 · Not classified · Z-1238-2012: The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control 
- Nov 10, 2011 · Not classified · Z-1240-2012: The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control 
- Jun 22, 2011 · Not classified · Z-1195-2012: The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.
- May 10, 2011 · Not classified · Z-2605-2011: The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in

## Indications for use
Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System 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/K994278
Methodology: https://510kreport.com/methodology