# P150014: Cobas HBV Test

- Pathway: PMA
- Applicant: Roche Molecular Systems, Inc.
- Decided: Oct 14, 2015 after 173 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
- Jul 15, 2016 · Class II · Z-0110-2017: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarif

Source page: https://510kreport.com/device/P150014
Methodology: https://510kreport.com/methodology