# P150015: Cobas HCV Test

- Pathway: PMA
- Applicant: Roche Molecular Systems, Inc.
- Decided: Oct 14, 2015 after 170 days
- Product code: MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K221007: cobas HCV (2022), 1 descendant of its own
- K252484: cobas HCV (2025), 0 descendants of its own

Source page: https://510kreport.com/device/P150015
Methodology: https://510kreport.com/methodology