# K230440: Xpert® Xpress CoV-2 plus

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid®
- Decided: Oct 13, 2023 after 234 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: 2 generations back to DEN200031 (2021). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211079: BioFire COVID-19 Test 2, Biofire Defense, LLC (2021) Summary page 5.

## Most influential descendants
- K242109: Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (2025), 0 descendants of its own

## Indications for use
The Xpert Xpress CoV-2 plus test, performed on the GeneXpert Dx and GeneXpert Infinity Systems, 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/K230440
Methodology: https://510kreport.com/methodology