Capillary Electrochromatography
Device Approval
Microfluidic Analytical Techniques
Ultrafast differential ion mobility spectrometry at extreme electric fields in multichannel microchips. (1/106)
(+info)Enzyme-release capillary as a facile enzymatic biosensing part for a capillary-assembled microchip. (2/106)
A simple capillary enzymatic biosensor was developed. This was prepared by simply coating a dissolvable membrane containing enzyme/s on the inner wall of a square glass capillary. An easy measurement was carried out by capillary force sample introduction with concurrent enzyme release and a reaction with a certain substrate. Enzyme-release capillary (ERC) biosensors showed long-term storage stability of at least two weeks for a beta-galactoside derivative and glucose. Moreover, this could be integrated on a capillary-assembled microchip (CAs-CHIP) to broaden its multiple analyte sensing potential for clinical diagnostic applications. (+info)High-sensitivity microfluidic calorimeters for biological and chemical applications. (3/106)
(+info)High-throughput flow alignment of barcoded hydrogel microparticles. (4/106)
(+info)Microfluidic pneumatic logic circuits and digital pneumatic microprocessors for integrated microfluidic systems. (5/106)
(+info)Polymer microchip CE of proteins either off- or on-chip labeled with chameleon dye for simplified analysis. (6/106)
(+info)Localized heating on silicon field effect transistors: device fabrication and temperature measurements in fluid. (7/106)
(+info)On-chip activation and subsequent detection of individual antigen-specific T cells. (8/106)
(+info)Capillary electrochromatography (CEC) is a separation technique that combines the principles of capillary electrophoresis and high-performance liquid chromatography (HPLC). In CEC, an electric field is applied to a liquid flowing through a narrow fused-silica capillary tube packed with a stationary phase.
The analytes (the substances being separated) are carried by the electroosmotic flow of the liquid and interact with the stationary phase as they migrate through the capillary, resulting in separation based on both charge and size/hydrophobicity. CEC offers high efficiency, resolution, and sensitivity for the separation of a wide range of analytes, including small molecules, peptides, proteins, and nucleic acids.
The medical definition of Capillary Electrochromatography is not commonly used as it is primarily employed in research settings for the analysis of various biological samples, pharmaceuticals, and environmental pollutants.
"Device approval" is a term used to describe the process by which a medical device is determined to be safe and effective for use in patients by regulatory authorities, such as the U.S. Food and Drug Administration (FDA). The approval process typically involves a rigorous evaluation of the device's design, performance, and safety data, as well as a review of the manufacturer's quality systems and labeling.
The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices in the United States. The CDRH uses a risk-based classification system to determine the level of regulatory control needed for each device. Class I devices are considered low risk, Class II devices are moderate risk, and Class III devices are high risk.
For Class III devices, which include life-sustaining or life-supporting devices, as well as those that present a potential unreasonable risk of illness or injury, the approval process typically involves a premarket approval (PMA) application. This requires the submission of comprehensive scientific evidence to demonstrate the safety and effectiveness of the device.
For Class II devices, which include moderate-risk devices such as infusion pumps and powered wheelchairs, the approval process may involve a premarket notification (510(k)) submission. This requires the manufacturer to demonstrate that their device is substantially equivalent to a predicate device that is already legally marketed in the United States.
Once a medical device has been approved for marketing, the FDA continues to monitor its safety and effectiveness through post-market surveillance programs. Manufacturers are required to report any adverse events or product problems to the FDA, and the agency may take regulatory action if necessary to protect public health.
Equipment design, in the medical context, refers to the process of creating and developing medical equipment and devices, such as surgical instruments, diagnostic machines, or assistive technologies. This process involves several stages, including:
1. Identifying user needs and requirements
2. Concept development and brainstorming
3. Prototyping and testing
4. Design for manufacturing and assembly
5. Safety and regulatory compliance
6. Verification and validation
7. Training and support
The goal of equipment design is to create safe, effective, and efficient medical devices that meet the needs of healthcare providers and patients while complying with relevant regulations and standards. The design process typically involves a multidisciplinary team of engineers, clinicians, designers, and researchers who work together to develop innovative solutions that improve patient care and outcomes.
Microfluidic analytical techniques refer to the use of microfluidics, which is the manipulation of fluids in channels with dimensions of tens to hundreds of micrometers, for analytical measurements and applications. These techniques involve the integration of various functional components such as pumps, valves, mixers, and detectors onto a single chip or platform to perform chemical, biochemical, or biological analyses.
Microfluidic analytical techniques offer several advantages over traditional analytical methods, including reduced sample and reagent consumption, faster analysis times, increased sensitivity and throughput, and improved automation and portability. Examples of microfluidic analytical techniques include lab-on-a-chip devices, digital microfluidics, bead-based assays, and micro total analysis systems (μTAS). These techniques have found applications in various fields such as diagnostics, drug discovery, environmental monitoring, and food safety.
An Intrauterine Device (IUD) is a long-acting, reversible contraceptive device that is inserted into the uterus to prevent pregnancy. It is a small T-shaped piece of flexible plastic with strings attached to it for removal. There are two types of IUDs available: hormonal and copper. Hormonal IUDs release progestin, which thickens cervical mucus and thins the lining of the uterus, preventing sperm from reaching and fertilizing an egg. Copper IUDs, on the other hand, produce an inflammatory reaction in the uterus that is toxic to sperm and eggs, preventing fertilization.
IUDs are more than 99% effective at preventing pregnancy and can remain in place for several years, depending on the type. They are easily removable by a healthcare provider if a woman wants to become pregnant or choose another form of contraception. IUDs do not protect against sexually transmitted infections (STIs), so it is important to use condoms in addition to an IUD for protection against STIs.
In summary, Intrauterine Devices are small, T-shaped plastic devices that are inserted into the uterus to prevent pregnancy. They come in two types: hormonal and copper, both of which work by preventing fertilization. IUDs are highly effective, long-acting, and reversible forms of contraception.
Equipment safety in a medical context refers to the measures taken to ensure that medical equipment is free from potential harm or risks to patients, healthcare providers, and others who may come into contact with the equipment. This includes:
1. Designing and manufacturing the equipment to meet safety standards and regulations.
2. Properly maintaining and inspecting the equipment to ensure it remains safe over time.
3. Providing proper training for healthcare providers on how to use the equipment safely.
4. Implementing safeguards, such as alarms and warnings, to alert users of potential hazards.
5. Conducting regular risk assessments to identify and address any potential safety concerns.
6. Reporting and investigating any incidents or accidents involving the equipment to determine their cause and prevent future occurrences.