# K043125: Orion Diagnostica Uniq Pinp Ria

- Pathway: 510(k) (Traditional)
- Applicant: Orion Diagnostica, OY
- Decided: May 4, 2005 after 173 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Orion Diagnostica UniQ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used as an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K043125
Methodology: https://510kreport.com/methodology