This project

is developed

by TIRF Labs

www.TIRF-Labs.com

T: 919.463.9545

i-Diagnostics®
The Handheld Future of Precision Medicine

Copyright © 2021, TIRF Labs, Inc. All photographic images, schemes and text located at this web site are protected by US copyright laws and international treaties.

To use them, please contact TIRF Labs at: info@TIRF-Labs.com. Include a description of the purpose and location for placement.  

Terms and ConditionsPrivacy PolicyLiterature Cited FDA Compliance Copyright Credits

i-diagnostics@TIRF-Labs.com

Disclaimer


Neither human subjects nor laboratory animals are involved in this project. Genetically modified organisms and biologically hazardous materials are not involved either. Our collaborators, who do perform  regulated studies, carefully comply with the respective government protocols and rules.


The field of lifesciences, in general, and the area of molecular biology, in particular, operate with powerful technologies that have strong potential for improving quality of our life. However, these tools, if used improperly, can cause adverse effects.  We believe that scientists should be responsible for results of their studies. It is our company policy that our associates  and collaborators foresee possible adverse effects and adhere to the highest moral and ethical standards to avoid possible adverse effects. We do not develop and do not support the development of controversial biological applications.  




Compliance with FDA Guidance


TIRF Labs complies with the U.S. Food and Drug Administration guidance, including the following:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm


The Software guidance documents http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089543.htm


http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf


Design Considerations for Devices Intended for Home Use

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM331681.pdf


Guidance for Molecular Diagnostic Instruments with Combined Diagnostic and Research Functions

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf




Copyright Credits


We are grateful to the National Institutes of Health, Mr. Michael Astrachan - XVIVO Scientific Animation, Genome British Columbia,

The Howard Hughes Medical Institute, and Dr. David Goodsell, The Scripps Research Institute, for their kind permissions to use their

videos and images for the purpose of i-Diagnostics project.




Risks and challenges


TIRF Labs has been working on molecular diagnostics for the last forteen years and has created a family of TIRF instruments, including bench-top, portable, and handheld TIRF biosensors. We have assembled a group of scientists and engineers with vast experience in all relevant fields. However, a project of such scale as i-Diagnostics involves new risks. To mitigate the risks of transition to clinical analyses , we are offering to the biodetection community uTIRF biodetection station and i-Diagnostics Application Development Kit (ADK). uTIRF-ADK will involve a number of diagnostics research groups with their own networks, which will facilitate entering of i-Diagnostics into conservative area of clinical analyses. The research and development for uTIRF and i-Diagnostics have worked, the prototyping and low-volume manufacturing of these products has been done. Now, a group of risks will be associated with the transition from low-volume manufacturing to volume production. To mitigate these risks, we are establishing parallel contacts with alternative manufacturing partners and collaborators to assure multiple possible channels for production. If a setback does arise in one of the channels, we will use an alternative channel. i-Diagnostics is a sophisticated technology. We are using a number of unique methods and production technologies. We believe that we are able to foresee and minimize risks associated with these methods in order to deliver uTIRF and i-Diagnostics ADK to our customers with full satisfaction. Keeping our existing and prospective customers updated about our progress and receiving feedback from them is our priority.