cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240867 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)
This device is a Respiratory Specimen Nucleic Acid SARS-CoV-2 Test, classified as a Class II in vitro diagnostic (IVD) device. It is designed for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens using real-time reverse transcription polymerase chain reaction (RT-PCR) technology. The test identifies the presence of viral nucleic acids to aid in the diagnosis of COVID-19 infections. It incorporates an RNA Internal Control to monitor specimen validity and inhibit amplification.
The cobas SARS-CoV-2 Qualitative is intended for use on the cobas 5800, 6800, and 8800 Systems and is supplied as a single-use reagent kit. Specimens must be collected in appropriate transport media and processed within specified timeframes to ensure accuracy. The device is regulated under FDA 510(k) clearance (K240867) and falls under the regulatory category of 866.3981. It is not MRI-compatible and requires adherence to standard laboratory protocols for handling, storage, and disposal.
Frequently asked questions
What is the cobas® SARS-CoV-2 Qualitative Test used for?
This test is designed for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens. It uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology to identify viral nucleic acids, aiding in the diagnosis of COVID-19 infections. The included RNA Internal Control ensures specimen validity and monitors amplification inhibition, improving test reliability.
How is the cobas® SARS-CoV-2 Qualitative Test supplied, and is it single-use?
The test is supplied as a single-use reagent kit, meaning each kit is intended for one use only. This ensures sterility and prevents cross-contamination between samples. Specimens must be collected in appropriate transport media and processed within specified timeframes to maintain accuracy.
Does this test require any special handling or storage conditions?
The test follows standard laboratory protocols for handling, storage, and disposal. While specific storage conditions are not detailed in the provided data, it is critical to adhere to manufacturer guidelines to preserve reagent integrity and ensure accurate results. Always store the kit as directed to avoid degradation.
Can this test be used on other platforms besides the cobas® 5800/6800/8800 Systems?
No, this test is specifically designed for use exclusively on the cobas® 5800, 6800, and 8800 Systems. Compatibility with other platforms is not supported, and using it on unauthorized systems may compromise test performance or accuracy.
Is the cobas® SARS-CoV-2 Qualitative Test MRI-compatible?
No, this test is not MRI-compatible. The device itself is not intended for use in magnetic resonance imaging environments, and exposure to MRI fields could potentially affect its performance or integrity. Always follow standard laboratory protocols for handling and storage.
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® SARS-CoV-2 Qualitative - Roche Diagnostics USA, MS - cobas 5800/6800/8800 SARS-CoV-2 Qualitative 192T, 480T (IVD ..., cobas® SARS-CoV-2 & Influenza A/B v2, Qualitative nucleic acid test for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240867 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA 510(k) K240867 24 fields · synced Oct 5, 2026