# K964764: Opus Bone Alp

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jan 24, 1997 after 58 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.
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. The FDA summary names its predicate without a number.
- (no number) Hybritech Tandem-R Ostase: named in the summary without a submission number

## Indications for use
OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.

Source page: https://510kreport.com/device/K964764
Methodology: https://510kreport.com/methodology