# K200475: IDS-iSYS Ostase BAP

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Sep 30, 2020 after 217 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)
- K972666: Tandem-MP Ostase Immunoenzymetric Assay, Hybritech, Inc. (1997) Summary page 5.

## Indications for use
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget’s disease.

Source page: https://510kreport.com/device/K200475
Methodology: https://510kreport.com/methodology