# P040004: Advia Centaur HBC Total Readypack Reagents/Advia Centaur HBC Total Quality Control Materials

- Pathway: PMA
- Applicant: Siemens Healthcare Diagnostics
- Decided: Dec 22, 2004 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: 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 15, 2014 · Class II · Z-0103-2015: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
- Sep 15, 2014 · Class II · Z-0102-2015: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Source page: https://510kreport.com/device/P040004
Methodology: https://510kreport.com/methodology