# K143206: AmpliVue Bordetella Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Dec 10, 2014 after 33 days
- Product code: OZZ (Bordetella Pertussis Dna Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070013 (2008). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma, Meridian Bioscience, Inc. (2014) Summary page 8.

## Indications for use
The AmpliVue® Bordetella Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The AmpliVue® Bordetella Assay utilizes helicase-dependent amplification (HDA) of the insertion sequence IS481 and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. The IS481 sequence can also be found in strains of other organisms (i.e., B. holmesii and B. bronchiseptica). B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the AmpliVue® Bordetella Assay do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the AmpliVue® Bordetella Assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. The AmpliVue® Bordetella Assay is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K143206
Methodology: https://510kreport.com/methodology