# P100001: Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator/Anti Hbe Controls

- Pathway: PMA
- Applicant: Ortho-Clinical Diagnostics
- Decided: Jul 20, 2011 after 537 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 1, 2018 · Class II · Z-0687-2019: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicate

Source page: https://510kreport.com/device/P100001
Methodology: https://510kreport.com/methodology