Siemens Healthcare Diagnostics is committed to providing clinicians with vital diagnostic information through its comprehensive portfolio of clinical diagnostics systems and solutions. This includes the CLINITEK Status family of urinalysis analyzers which feature automated and reliable testing, optional connectivity capabilities, and a broad test menu to support patient care. The new CLINITEK Status+ Analyzer offers additional enhancements like automated quality checks and printed records for accurate results.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
The Current Regulatory Thinking in Reprocessing seminar discusses standards and guidance for reprocessing and reusable medical devices as well as insights into the development and validation process.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
The secret formula to getting health tech to marketDr Hugh Harvey
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
The Current Regulatory Thinking in Reprocessing seminar discusses standards and guidance for reprocessing and reusable medical devices as well as insights into the development and validation process.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
The secret formula to getting health tech to marketDr Hugh Harvey
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
Modern mobile devices by their capabilities are almost equal to office computers. For working with different types of document or an access to corporate resources, employees often use their own tablets and smartphones ignoring the prohibition of IT service. This BYOD scenario is impossible to avoid. BYOD brings significant risks and often results in confidential data breaches. The usual restrictions are no longer working, businesses are unable to stop employees from bringing personal devices into the workplace, and today every company needs more mobile and flexible solutions.
Es una diapositiva que les voy a mostrar algunos detalles de mi region tiene imagenes y fotos graficos orgvanisadores video audio transiciones colores y mucho vida es importante para encontra informacion sobre esta region ubicada en la selva alta considerada la ciudad mas alta del mundo tiene letras con el formato de power point
March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
Development of the PanDx Integrated Diagnostic Platform
Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development
UC Berkeley, March 5, 2015
After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.
Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
These slides use concepts from my (Jeff Funk) course entitled Biz Models for Hi-Tech Products to analyze the business model for Infra V’s Smart Watch. This watch can continuously monitor glucose using a non-invasive spectrometric process, which enables better management of diabetes through more timely insulin injections. The watch replaces the widely used finger-pricking method that is painful for users and thus discourages effective monitoring of a patient’s glucose levels. The watch is also smaller and cheaper than other methods of continuous monitoring. These slides describe the specific value proposition for patients and doctors other aspects of the business model such as the method of value capture, scope of activities, and method of strategic control.
LC-MS/MS Solutions for Toxicology and Clinical ResearchSCIEX
La spectrométrie de masse en tandem est devenue un outil essentiel pour les applications cliniques et la recherche biomédicale impliquant l’analyse de biomarqueurs. Contrairement aux méthodes classiques de dosage immunologique, l’analyse par chromatographie liquide couplée à la spectrométrie de masse (LC-MS/MS) permet une analyse très sélective et spécifique de composés multiples en un seul passage, conduisant à une plus grande confiance dans les résultats et permettant de nouvelles découvertes. La LC-MS/MS est idéalement adaptée pour identifier les hormones stéroïdes, la vitamine D et ses métabolites, des peptides ou des protéines et d'autres composés dans des matrices complexes tels que le sang, l'urine, la salive et les lysats céllulaires. Aujourd'hui, la LC-MS/MS est également la méthode préférée de l'analyse médico-légale surpassant les techniques d'analyse traditionnelles - à la fois à des fins de dépistage et de confirmation.
Cette présentation vous présentera comment SCIEX pourrait contribuer à améliorer le monde dans lequel nous vivons en permettant aux scientifiques et aux analystes de laboratoire de trouver des réponses aux défis analytiques complexes auxquels ils sont confrontés.
2. Printed record to help avoid
transcription errors
Ready for connectivity when
you are – via simple upgrade kit
Detects common sample
interferences2
and provides
a printed comment if it detects
certain interferences that could
compromise the result (availability
dependent on strip type)
Enhanced clinical information for more precise
decision making
New advanced technology inside
the CLINITEK Status+ Analyzer performs
automated quality checks on every test
Introducing the
Ensures consistent interpretation of results by removing the
subjectivity of visual reading – automatically times and reads
every specimen
NEW CLINITEK Status+ Analyzer – an easy-to-use,
automated analyzer designed to deliver quick,
accurate, reliable results
1. Available for sale in the U.S. and Japan only.
2. Feature not available in the U.S.
The broadest menu for point-of-care urinalysis testing on one analyzer
Product Tests Clinical Utility
Multistix® 10 SG
and family of
test strips
Most widely used
urinalysis test strips
Routine testing
CLINITEK®
Microalbumin family
Albumin-to-Creatinine
ratio test
Detection of early kidney
disease for patients with
confirmed diabetes
MULTISTIX PRO®
family1
Protein-to-Creatinine
ratio test
Detection of early kidney
disease for high-risk
patients
CLINITEST® hCG Qualitative hCG test Pregnancy testing
of CLINITEK Status®
analyzers
designed to improve in-office
urine testing
next generation
Checks integrity of each test strip
for exposure to humidity and prevents
reporting if exposure is detected
(available on strips with leukocyte pad)
Identifies type of strip
automatically, eliminating need
for the operator to key
in the strip configuration
Comprehensive urine test menu
– including hCG pregnancy testing
3. The CLINITEK Status Connect System, ready to help you
Simplifies data entry and integrates with
practice management software
• Transmits results automatically via
middleware for integration into a central
database or electronic medical records
• Flexible connectivity options
– serial, Ethernet or wireless connections
– supports HL7 and POCT1-A2 protocols
• Supports quality control testing and allows
customization of quality control regimen
• Optional barcode reader available for
accurate patient and operator ID entry
• Prevents unauthorized use through
programmable operator authorization
The CLINITEK Status Connect System –
combines the new CLINITEK Status+ Analyzer
and our advanced connector platform
step into the future
Connector platform for
results transmission
Optional barcode
data entry
QC testing and
lockout
Operator lockout and
access control
CLINITEK Status+
Analyzer
4. Choose the CLINITEK Status
urinalysis analyzer that
Do you need... CLINITEK Status+
Analyzer
CLINITEK Status
Connect System
• Printed records
• Automatic checks
– Automatic humidity exposure check
– Sample interference notes1
– Automatic identification of strip type
• Lot and expiration entry
with each test
• Test results storage
(up to 950 patient tests)
• Operator ID Storage
(up to 700 operators)
• QC testing (up to 200 results)
• QC test reminders or
mandatory testing
• Optional barcode scanning
(patient/operator/lot/exp)
• Optional wireless connectivity
• Connectivity to data management
software or LIS/HIS
• HL7 and POCT1-A2 protocols
Trust and confidence based on a heritage of delivering
reliable solutions
• Most widely used system worldwide; over 60,000 CLINITEK
analyzers shipped
• CLINITEK and Multistix – the brands clinicians know and trust
• CLIA-waived and CE-marked
CLINITEK – a legacy of innovation in urinalysis
testing from Siemens Healthcare Diagnostics
CLINITEK Status Family of Analyzers – the next generation of urinalysis
analyzers developed with the help of continuous customer input
meets your needs
1. Feature not available in the U.S.
To learn more about this exciting new offering, contact your
local Siemens Healthcare Representative or visit our web site at
www.siemens.com/urinalysis or www.usa.siemens.com/urinalysis.
Siemens leads the way in urinalysis testing
with world-class service
The next generation
of urinalysis analyzers
Connectivity provides easy access to patient results
Automated hCG pregnancy testing