# K173498: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin Molecular, LLC
- Decided: Aug 13, 2018 after 273 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: 8 generations back to DEN070013 (2008). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit, Luminex Corporation (2017) Summary page 6.

## Most influential descendants
- K183223: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), 0 descendants of its own

## Indications for use
Simplexa™ Bordetella Direct MOL2750 The DiaSorin Molecular Simplexa™ Bordetella Direct MOL2750 assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids from frozen nasopharyngeal (NPS) specimens from patients with signs and symptoms of Bordetella infection of the respiratory tract. The Simplexa™ Bordetella Direct MOL2750 assay is performed on the LIAISON® MDX instrument and utilizes real-time PCR amplification to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome and to detect B. parapertussis by targeting the IS1001 insertional element of the B. parapertussis genome. The IS481 insertional element can also be present in B. holmesii and B. bronchiseptica. Specimens collected from patients with respiratory infection caused by B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. 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 Simplexa™ Bordetella Direct MOL2750 assay do not preclude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Simplexa™ Bordetella Direct MOL2750 assay should be used with other clinical findings and epidemiological information as an aid in diagnosis of Bordetella infection. Test results should not be used as the sole basis for treatment or other patient management decisions. Simplexa™ Bordetella Positive Control Pack MOL 2760 The Simplexa™ Bordetella Positive Control Pack MOL2760 is intended to be used as a control with the Simplexa™ Bordetella Direct kit. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K173498
Methodology: https://510kreport.com/methodology