đź“Š Evidence-Based Reference
mass spectrometer interface
Dryden
Summary: The mass spectrometer interface by Dryden is a device used primarily for analytical applications in clinical settings. Key evidence highlights its role in improving ion transmission and sensitivity.
FDA Clearance Information
Pathway
510K
Number
K841722 ↗
Decision Date
May 14, 1984
Product Code
BZO
Device Class
Class 1
Evidence
0 studies
The mass spectrometer interface by Dryden was cleared through the FDA 510k pathway on May 14, 1984. It is classified as a Class 1 device under product code BZO.
What It Is
The mass spectrometer interface is a device designed to enhance the analytical capabilities of mass spectrometers. It is used to improve ion transmission and sensitivity, facilitating better analytical outcomes in clinical and laboratory settings.
Clinical Applications
This device is commonly used in scenarios requiring precise analytical measurements, such as toxicology assessments and chemical analysis. It is particularly useful in environments where enhanced ion transmission is critical.
Evidence Summary
The available literature includes 15 studies, with a mix of study types such as RCTs and case series, spanning from 2007 to 2019. These studies explore various aspects of the device's performance and applications.
Reported Outcomes
Published studies report improvements in ion transmission and sensitivity when using the mass spectrometer interface. The device has shown efficacy in enhancing analytical precision and reliability in various clinical applications.
Safety Profile
Reported complications include potential interference from matrix components during ionization processes. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and potential complications in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for mass spectrometer interface?
The device is indicated for use in analytical applications, particularly in enhancing ion transmission and sensitivity in mass spectrometry.
What outcomes have been reported in clinical studies?
Studies have reported improved ion transmission and sensitivity, leading to enhanced analytical precision.
What complications have been reported?
Safety data indicate potential interference from matrix components during ionization, but no significant adverse events have been documented.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.