# K242109: Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

- Pathway: 510(k) (Dual Track)
- Applicant: Cepheid®
- Decided: Jan 15, 2025 after 180 days
- Product code: QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200031 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230440: Xpert® Xpress CoV-2 plus, Cepheid® (2023) Summary page 7.

## Indications for use
The Xpert Xpress CoV-2 plus test, performed on the GeneXpert Xpress System, is a rapid real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection. The Xpert Xpress CoV-2 plus test is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other pathogens. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis and patient management decisions.

Source page: https://510kreport.com/device/K242109
Methodology: https://510kreport.com/methodology