# P100020: Cobas HPV Test

- Pathway: PMA
- Applicant: Roche Molecular Systems, Inc.
- Decided: Apr 19, 2011 after 322 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
- Nov 19, 2020 · Class II · Z-0846-2021: Dirty Lens May Cause Invalid or False Positive Results

Source page: https://510kreport.com/device/P100020
Methodology: https://510kreport.com/methodology