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LC-MS Medical Devices for In Vitro Diagnostic Use
Confidence in laboratory developed tests
Our family of liquid chromatography mass spectrometry (LC-MS) instruments for in vitro diagnostics provides clinical labs with consistent reliable results, faster. These comprehensive, reliable LC-MS platform solutions offer greater flexibility than immunoassays, facilitate cost savings and enable clinical laboratories to achieve their productivity goals, while ensuring confidence in results of laboratory developed tests (LDTs).
These Class I LC-MS medical devices leverage the power of a complete software suite conforming to in vitro diagnostic (IVD) requirements and offering an optional laboratory information system (LIS) connection.
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HPLC medical device
Vanquish MD HPLC
The Thermo Scientific Vanquish MD HPLC is the ideal chromatographic separations system for laboratories where analyte resolution is critical. This small, powerful HPLC system meets analytical needs, as well as space and budget limitations with the throughput, speed and sample capacity to boost workflow productivity for laboratory developed tests.
Mass spectrometer (MS) medical devices
TSQ Quantis MD Series Mass Spectrometer
Used by clinical diagnostic laboratories to meet routine requirements for laboratory tests, the Thermo Scientific TSQ Quantis MD Series mass spectrometer provides the sensitivity needed for routine quantitative analyses with remarkable speed, robustness and an extended mass range.
TSQ Altis MD Series Mass Spectrometer
Used by clinical diagnostic laboratories to address challenging analyte requirements for laboratory developed tests, the Thermo Scientific TSQ Altis MD mass spectrometer provides ultimate sensitivity for demanding quantitative analyses with remarkable speed, robustness and the ability to improve selectivity with H-SRM.
Five Reasons to Implement LC-MS Platforms for your Laboratory Developed Tests
Implementing LC-MS requires sufficient justification and commitment of resources but can have a very positive impact on clinical and business goals. Download our smart note to learn more.
Software for LC-MS medical devices
TraceFinder LDT Software
For a workflow-oriented approach to high-throughput quantitation, the Class I medical devices are powered by the integral Thermo Scientific TraceFinder LDT software, which is batch-centric and provides a seamless approach to robust, reliable, high throughput quantitation with tools to automate or accelerate the processes of creating methods, loading samples, generating data, manually reviewing and editing results, and finalizing the data review and reporting process.
B-Link® Bi-Directional LIS Connection
Expedited by the optional B-Link LIS/LIMS Connector, B-Link is a Universal LIS/LIMS Connector validated for TraceFinder LDT software. Comprised of a downloadable software package of middleware capable of providing bidirectional communication between TraceFinder software and the Laboratory Information System (LIS), the B-Link LIS/LIMS Connector software is installed on the TSQ Altis MD Series data system or TSQ Quantis MD Series data system—there is no need for any additional hardware.
The B-link LIS/LIMS Connector enables the exchange of compliant LIS system file formats commonly used for test requests and reports.
Intended Use, indications, contraindications and limitations
| HPLC System Vanquish MD | Mass Spectrometers TSQ Altis MD Series, TSQ Quantis MD Series | |
|---|---|---|
| Intended Use | General purpose laboratory instruments intended to separate drugs or compounds in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. | Intended to identify and quantify inorganic and organic compound in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. |
| Indications for Use | Used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow. | Used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow. |
| Contraindications of Use | For in vitro diagnostic applications only. The Vanquish MD HPLC is to be operated only with hardware or software approved for in vitro diagnostic application. | For in vitro diagnostic applications only. The TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers are to be operated only with hardware or software labeled for in vitro diagnostic use. |
| Limitations of Use | Compatible with the following Thermo Scientific instruments: TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers. | Compatible with the following Thermo Scientific instruments: Vanquish MD HPLC. |
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For in-vitro diagnostic use. Specifications subject to change. Availability of product in each country depends on local regulatory marketing authorization status.
This information is presented as an example of the capabilities of Thermo Fisher Scientific products. It is not intended to encourage use of these products in any manner that might infringe the intellectual property rights of others. Specifications, terms and pricing are subject to change.