# P080027: Oraquick HCV Rapid Antibody Test

- Pathway: PMA
- Applicant: OraSure Technologies, Inc.
- Decided: Jun 25, 2010 after 609 days
- Product code: MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3169
- 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
- Jan 15, 2016 · Class III · Z-1509-2016: OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their custom

Source page: https://510kreport.com/device/P080027
Methodology: https://510kreport.com/methodology