# K981373: Alkphase-B Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Metra Biosystems, Inc.
- Decided: May 27, 1998 after 41 days
- Product code: CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 14, 2016 · Class II · Z-1797-2018: There is a possibility of low volume and/or leaking standard bottles.

## Indications for use
Measurement of BAP is intended for use as an aid in the: management of postmenopausal osteoporosis and Paget’s disease. monitoring of postmenopausal women on hormonal or bisphosphonate therapy prediction of skeletal response to hormonal therapy in postmenopausal women.

Source page: https://510kreport.com/device/K981373
Methodology: https://510kreport.com/methodology