Xpert MRSA/SA Nasal Assay
FDA 510(k)Class II (US FDA 510(k))
by Cepheid
Identifiers
- 510(k) Number
- K100822 FDA 510(k)
- FDA Product Code
- NQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1640 FDA 510(k)
- Regulation Number
- 866.1640 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xpert MRSA/SA Nasal Assay is a qualitative in vitro diagnostic test designed for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus from nasal swabs. It is intended for use in patients at risk for nasal colonization to support the implementation of infection control strategies.
This test is performed using the GeneXpert Dx System. It has received FDA 510k clearance and is classified as a nucleic acid amplification test for the direct detection of MRSA. The assay is not intended to diagnose, guide, or monitor treatment for infections, and a negative result does not preclude nasal colonization.
Frequently asked questions
What is the intended use of the Xpert MRSA/SA Nasal Assay?
This assay is a qualitative in vitro diagnostic test designed to detect Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs. It is intended for use in patients identified as being at risk for nasal colonization to assist healthcare facilities in implementing effective infection control strategies.
What equipment is required to perform this test?
The Xpert MRSA/SA Nasal Assay is specifically designed to be performed using the GeneXpert Dx System. The assay utilizes nucleic acid amplification technology to provide direct detection of the target organisms from the collected specimen.
Can this test be used to diagnose an active infection?
No, this assay is not intended to diagnose, guide, or monitor treatment for active infections. Furthermore, a negative result from this test does not definitively preclude the possibility of nasal colonization, as the test is primarily used for screening purposes in at-risk populations.
What is the regulatory status of this device?
The Xpert MRSA/SA Nasal Assay has received FDA 510k clearance under the number K100822. It is classified as a nucleic acid amplification test for the direct detection of MRSA, falling under the microbiology medical specialty.
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® SA Nasal Complete - Cepheid, PDF Xpert SA Nasal Complete ENGLISH Package Insert 300-8799 Rev J.fm, PDF Xpert® SA Nasal Complete - 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 | K100822 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA 510(k) K100822 24 fields · synced Sep 21, 2026