# K000471: Future Diagnostics B.V. Stat-Intraoperative Intact PTH Kit

- Pathway: 510(k) (Traditional)
- Applicant: Future Diagnostics B.V.
- Decided: Apr 11, 2000 after 57 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Dec 6, 2022 · Class II · Z-1016-2023: Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

Source page: https://510kreport.com/device/K000471
Methodology: https://510kreport.com/methodology