Xpert MRSA/SA BC Blood Culture Assay Model GXMRSA/SA-BC-10
FDA 510(k)Class II (US FDA 510(k))
by Cepheid
Identifiers
- 510(k) Number
- K101879 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 BC Blood Culture Assay is a qualitative in vitro diagnostic test designed for the rapid and simultaneous detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus DNA. It is performed directly from gram-positive blood cultures to identify these specific pathogens.
This assay is intended for use on GeneXpert instrument systems. It has received FDA 510(k) clearance for its intended use as a nucleic acid amplification test.
Frequently asked questions
What is the primary purpose of the Xpert MRSA/SA BC assay?
This assay is a qualitative in vitro diagnostic test designed to simultaneously detect the presence of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from gram-positive blood cultures.
Which equipment is required to run this assay?
The Xpert MRSA/SA BC assay is specifically designed for use on Cepheid GeneXpert instrument systems, which perform the nucleic acid amplification process required to identify the target pathogens.
What is the regulatory status of this device?
The Xpert MRSA/SA BC assay, model GXMRSA/SA-BC-10, has received FDA 510(k) clearance as a nucleic acid amplification test for the detection of specific bacterial DNA.
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® MRSA/SA Blood Culture - Cepheid, Xpert® MRSA/SA Blood Culture - Detail - cepheid.com, PDF Xpert MRSA/SA Blood Culture - infomine.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 | K101879 | Class II | Active |
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Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA 510(k) K101879 24 fields · synced Oct 6, 2026