Identifiers
- 510(k) Number
- K142721 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 cobas MRSA/SA Test is a qualitative in vitro diagnostic real-time PCR assay for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA from nasal swabs. It functions as a nucleic acid amplification test (NAAT) to identify bacterial DNA, supporting infection prevention and control in healthcare environments.
This assay is designed for use on the cobas 4800 System and is intended for single-use in vitro diagnostic applications. It requires no additional sterility beyond its pre-packaged format and is classified as a Class II medical device under FDA regulations (K142721). No MRI safety considerations or reusable components are specified.
Frequently asked questions
What types of samples can the cobas MRSA/SA Test analyze, and how is it intended to be used in clinical settings?
The cobas MRSA/SA Test is designed to analyze nasal swab samples for the direct detection of methicillin-resistant *Staphylococcus aureus* (MRSA) and *Staphylococcus aureus* (SA) DNA. It functions as a nucleic acid amplification test (NAAT) to identify bacterial DNA, which helps support infection prevention and control in healthcare environments by rapidly identifying carriers or potential outbreaks.
Is the cobas MRSA/SA Test intended for single-use or reusable applications, and what sterility considerations apply?
The cobas MRSA/SA Test is explicitly intended for single-use in vitro diagnostic applications. No additional sterility measures are required beyond its pre-packaged format, ensuring usability without further preparation or reprocessing.
Which Roche platform is required to run the cobas MRSA/SA Test, and does it have any special handling requirements?
The cobas MRSA/SA Test is designed exclusively for use on the cobas 4800 System. Since it is a single-use assay, no reusable components or additional handling beyond standard NAAT protocols are specified, though adherence to the manufacturer’s instructions for the cobas 4800 System is essential for accurate results.
What regulatory pathway was followed for the cobas MRSA/SA Test, and what classification does it hold under FDA guidelines?
The cobas MRSA/SA Test was cleared through the FDA’s 510(k) pathway, specifically under a *Traditional* clearance process with a *Substantially Equivalent* determination. It is classified as a Class II medical device, aligning with its role as a nucleic acid amplification test for direct specimen analysis.
Are there any special storage or handling instructions for the cobas MRSA/SA Test beyond standard NAAT protocols?
While the provided data does not specify detailed storage instructions, the test is supplied in a pre-packaged format, implying it should be stored according to Roche Molecular Systems’ general guidelines for molecular diagnostics (e.g., refrigeration or room temperature as indicated on the packaging). Always follow the manufacturer’s instructions to maintain integrity and performance.
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: cobas® MRSA/SA Test, for use on the cobas® 4800 system, cobas® MRSA/SA Test for use on the cobas® 4800 System, cobas MRSA/SA Test - elabdoc-prod.roche.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142721 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA 510(k) K142721 24 fields · synced Sep 19, 2026