# P140021: Elecsys Anti-HCV II Immunoassay, Elecsys Precicontrol Anti-HCV

- Pathway: PMA
- Applicant: Roche Diagnostics Operations, Inc.
- Decided: Jun 11, 2015 after 253 days
- Product code: MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3169
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K221693: Elecsys Anti-HCV II (08837031190) (2023), 0 descendants of its own

Source page: https://510kreport.com/device/P140021
Methodology: https://510kreport.com/methodology