# P010051: Immulite 2000 Xpi Anti-HBC

- Pathway: PMA
- Applicant: Siemens Healthcare Diagnostics Products, Ltd.
- Decided: Jul 24, 2002 after 327 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
- Jan 2, 2018 · Class II · Z-1675-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

Source page: https://510kreport.com/device/P010051
Methodology: https://510kreport.com/methodology