Xpert Xpress CoV-2 Plus (XPRS-COV2-10)
FDA 510(k)Class II (US FDA 510(k))
by Cepheid®
Identifiers
- 510(k) Number
- K242109 FDA 510(k)
- FDA Product Code
- QQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xpert Xpress CoV-2 Plus (XPRS-COV2-10) is a Respiratory Specimen Nucleic Acid SARS-CoV-2 Test, classified as a Class II device under FDA regulations. It is designed for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal and anterior nasal swab specimens, enabling rapid identification of the virus in patients exhibiting respiratory symptoms.
This test is performed on the GeneXpert Dx and GeneXpert Infinity Systems and is intended for single-use in clinical microbiology settings. It is not sterile and requires proper handling as a non-sterile diagnostic device. The device holds FDA 510(k) clearance (K242109) under the Dual Track review process, with a decision date of January 15, 2025, and is regulated under 866.3981. No MRI safety or reusable specifications are indicated.
Frequently asked questions
What types of respiratory specimens can the Xpert Xpress CoV-2 Plus test detect SARS-CoV-2 nucleic acid in?
The Xpert Xpress CoV-2 Plus is designed specifically for nasopharyngeal and anterior nasal swab specimens. These are the two sample types it uses to detect SARS-CoV-2 nucleic acid, enabling rapid identification of the virus in patients with respiratory symptoms.
Is the Xpert Xpress CoV-2 Plus intended for reuse, or is it meant for single-use only?
The device is explicitly intended for single-use in clinical microbiology settings. It is not designed or approved for reuse, so each test cartridge should be used once and then discarded.
What systems does the Xpert Xpress CoV-2 Plus require to perform the test?
The test is performed exclusively on the GeneXpert Dx or GeneXpert Infinity Systems. These platforms are required to process the nasopharyngeal or anterior nasal swab specimens for SARS-CoV-2 detection.
Is the Xpert Xpress CoV-2 Plus sterile, or does it require special handling for non-sterile use?
The device is not sterile and must be handled as a non-sterile diagnostic tool. Proper aseptic techniques should be followed when preparing and processing specimens, as it is not intended for sterile procedures.
What regulatory pathway was followed for the FDA clearance of the Xpert Xpress CoV-2 Plus?
The device received FDA clearance under the Dual Track review process (510(k) clearance K242109) and was determined to be substantially equivalent to a predicate device. The decision was made by the Microbiology (MI) Advisory Committee, with a final clearance date of January 15, 2025.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Xpert® Xpress CoV-2 plus - Cepheid, Xpert® Xpress CoV-2 plus - Detail - cepheid.com, PDF Xpert Xpress CoV-2 plus - web-support.cepheid.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242109 | Class II | Active |
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Manufacturer
- Manufacturer
- Cepheid®
Sources (1)
- FDA 510(k) K242109 24 fields · synced Sep 19, 2026