# K972666: Tandem-MP Ostase Immunoenzymetric Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hybritech, Inc.
- Decided: Sep 11, 1997 after 57 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: 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 2.

## Most influential descendants
- K200475: IDS-iSYS Ostase BAP (2020), 0 descendants of its own

## Indications for use
The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. 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/K972666
Methodology: https://510kreport.com/methodology