# K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: May 2, 2017 after 131 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
Longest line of descent: 7 generations back to DEN070013 (2008). 8 ancestors in all.
2 later devices descend 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)
- K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma, Meridian Bioscience, Inc. (2014) Summary page 6.

## Most influential descendants
- K173498: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), 1 descendant of its own
- K183223: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), 0 descendants of its own

## Recalls of this device
- Feb 20, 2019 · Class II · Z-2282-2019: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impa

## Indications for use
The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES® Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis 131001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis 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 ARIES® Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES® Bordetella Assay is indicated for use with the ARIES® Systems.

Source page: https://510kreport.com/device/K163626
Methodology: https://510kreport.com/methodology