# P050042: Architect Anti-HCV Assay; Architect Anti-HCV Calibrator; Architect Anti-HCV Control

- Pathway: PMA
- Applicant: Abbott Laboratories, Inc.
- Decided: Jun 7, 2006 after 196 days
- Product code: MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3169
- Recalls of this device: 3 (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
- Mar 4, 2024 · Class II · Z-1479-2024: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely e
- Mar 4, 2024 · Class II · Z-1480-2024: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely e
- Jan 2, 2007 · Not classified · Z-0413-2007: The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in

Source page: https://510kreport.com/device/P050042
Methodology: https://510kreport.com/methodology