# P100042: Aptima HPV Assay

- Pathway: PMA
- Applicant: Gen-Probe Incorporated
- Decided: Oct 28, 2011 after 357 days
- Product code: OYB (Kit, Rna 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
- Feb 18, 2026 · Class II · Z-1586-2026: Due to product exhibiting potential to generate either invalid or false negative results.

Source page: https://510kreport.com/device/P100042
Methodology: https://510kreport.com/methodology