Identifiers
- 510(k) Number
- K140447 FDA 510(k)
- FDA Product Code
- OOI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2570 FDA 510(k)
- Regulation Number
- 862.2570 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Viper LT System is a Real-Time Nucleic Acid Amplification System designed for automated molecular diagnostics. It performs nucleic acid extraction, amplification, and detection to enable high-throughput testing in clinical chemistry applications, including HPV genotyping.
This bench-top system is intended for use in laboratory settings with automated workflows, reducing hands-on time. Supplied as a reusable device, it requires FDA 510K clearance and IVDR compliance. The system operates under non-sterile conditions and is not MRI-safe. Specific assay kits, such as the BD Onclarity HPV Assay, are used in conjunction with the system for testing.
Frequently asked questions
What types of clinical chemistry applications is the BD Viper LT System primarily designed for, and how does it streamline workflows?
The BD Viper LT System is specifically designed for automated molecular diagnostics in clinical chemistry, with a focus on high-throughput testing. It automates nucleic acid extraction, amplification, and detection, which significantly reduces hands-on time for laboratory staff. This system is particularly suited for HPV genotyping and other nucleic acid-based assays, enabling faster turnaround times and improved efficiency in laboratory workflows.
Is the BD Viper LT System reusable, and if so, what considerations should be taken into account for its maintenance?
Yes, the BD Viper LT System is supplied as a reusable device. Since it operates under non-sterile conditions, maintenance should include regular cleaning and calibration to ensure consistent performance. The system is not sterile, so proper disinfection protocols between uses are essential to prevent cross-contamination and maintain accuracy in molecular diagnostics.
What regulatory pathways has the BD Viper LT System undergone, and what does this mean for its use in clinical settings?
The BD Viper LT System has undergone FDA 510(k) clearance and IVDR compliance, confirming its safety, effectiveness, and adherence to regulatory standards. This means the system is authorized for use in clinical settings in the U.S. and the EU, respectively, ensuring it meets stringent requirements for molecular diagnostics. However, specific assay kits like the BD Onclarity HPV Assay must be used in conjunction with the system for authorized testing.
How does the BD Viper LT System integrate with other laboratory workflows, particularly for HPV genotyping?
The BD Viper LT System is designed to integrate seamlessly into automated laboratory workflows by handling nucleic acid extraction, amplification, and detection in a single, streamlined process. For HPV genotyping, it is intended to work with compatible assay kits like the BD Onclarity HPV Assay, enabling high-throughput testing with minimal manual intervention. This integration helps laboratories achieve faster results and improved efficiency in managing large sample volumes.
Are there any safety concerns related to the BD Viper LT System, such as compatibility with other equipment or environmental conditions?
The BD Viper LT System is not MRI-safe, so it should not be used in or near MRI environments. Additionally, since it operates under non-sterile conditions, proper laboratory practices—such as disinfection and maintenance—are critical to ensure reliable performance. The system is designed for bench-top use in controlled laboratory settings, where environmental factors like temperature and humidity can be managed to support accurate molecular diagnostics.
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: BD Viper™ LT system, BD Viper™, Becton Dickinson – Wikipedia, BD Viper™ LT system, Molecular diagnostics: BD Viper™ LT System, solution for HPV testing
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140447 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (2)
- FDA 510(k) K140447 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026