# K955647: Vidas Estradiol II (E2II) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Feb 6, 1996 after 56 days
- Product code: CHP (Radioimmunoassay, Estradiol)
- Device class: 1
- Regulation: 21 CFR 862.1260
- Recalls of this device: 2 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0867-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Mar 17, 2017 · Class II · Z-1801-2017: Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.

Source page: https://510kreport.com/device/K955647
Methodology: https://510kreport.com/methodology