# P080026: Abbott Realtime HBV Assay

- Pathway: PMA
- Applicant: Abbott Molecular, Inc.
- Decided: Aug 13, 2010 after 666 days
- Product code: MKT (Hepatitis Viral B Dna Detection)
- Device class: 2
- Regulation: 21 CFR 866.3174
- 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
- Dec 20, 2010 · Not classified · Z-1399-2011: Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package ins

Source page: https://510kreport.com/device/P080026
Methodology: https://510kreport.com/methodology