# K243753: cobas liat Bordetella panel nucleic acid test

- Pathway: 510(k) (Dual Track)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Nov 20, 2025 after 350 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143653: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), Nanosphere, Inc. (2015) Summary page 5.

## Indications for use
The cobas liat Bordetella panel nucleic acid test (cobas liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection. The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

Source page: https://510kreport.com/device/K243753
Methodology: https://510kreport.com/methodology