# P000044: Vitros Immunodiagnostic Products/Hbsag Reagent Pack,Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunr

- Pathway: PMA
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 27, 2001 after 177 days
- Product code: LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen))
- Device class: 2
- Regulation: 21 CFR 866.3172
- 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
- Feb 1, 2007 · Not classified · Z-0747-2007: Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to sample

Source page: https://510kreport.com/device/P000044
Methodology: https://510kreport.com/methodology