# K930810: Tandem-R Ostase Immunoradiometric Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hybritech, Inc.
- Decided: Jan 11, 1994 after 328 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961573: Tandem-R Ostase Immunoradiometric Assay (1996), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K930810
Methodology: https://510kreport.com/methodology