# K961573: Tandem-R Ostase Immunoradiometric Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hybritech, Inc.
- Decided: Aug 19, 1996 after 118 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: 1 generation back to K930810 (1994). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930810: Tandem-R Ostase Immunoradiometric Assay, Hybritech, Inc. (1994) Summary page 2.

## Most influential descendants
- K994278: Access Ostase Immunoenzymetric Assay (2000), 1 descendant of its own
- K972666: Tandem-MP Ostase Immunoenzymetric Assay (1997), 1 descendant of its own
- K232904: Access Ostase (2024), 0 descendants of its own
- K200475: IDS-iSYS Ostase BAP (2020), 0 descendants of its own

## Indications for use
Tandem-R Ostase, as an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease

Source page: https://510kreport.com/device/K961573
Methodology: https://510kreport.com/methodology