# K181029: Solana Bordetella Complete Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Jul 15, 2018 after 88 days
- Product code: OZZ (Bordetella Pertussis Dna Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- 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. FDA’s summary for it could not be read, so its predicates are not known.

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1948-2025: It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

Source page: https://510kreport.com/device/K181029
Methodology: https://510kreport.com/methodology