# P160037: BD Onclarity HPV Assay

- Pathway: PMA
- Applicant: Becton, Dickinson and Company
- Decided: Feb 12, 2018 after 537 days
- Product code: MAQ (Kit, Dna Detection, Human Papillomavirus)
- Device class: 3
- 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
- Jun 23, 2025 · Class II · Z-2162-2025: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

Source page: https://510kreport.com/device/P160037
Methodology: https://510kreport.com/methodology