We are empowering healthcare through accurate diagnostics development using cutting-edge technology.
InfinixBio designs and conducts studies to support 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests. We collaborate to design proof of concept, develop and test assays, and enable 510(k) submissions.
Our process involves working with various providers, including CROs, engineers, clinical labs, and device manufacturers. Partner with us for innovative diagnostic solutions that drive healthcare forward.
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InfinixBio designs and conducts studies to support both 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests. We work collaboratively to design the proof of concept for the diagnostic assay, develop and test the assay, enabling a 510(k) submission. Our process often involves working with many different providers ranging from CRO’s, engineers, clinical labs, to device manufacturers.
Get in TouchEach client is assigned a team that consists of a Project Manager (PM), executive contact, senior scientist, and support scientists. This team will lead the client’s project and work with the client on a one-on-one, fully collaborative basis, streamlining communication and minimizing risk. The PM will be a single point of contact, enabling quick and streamlined communication.
Our scientists are experts in their field and have a total of 50+ issued patents. They have a proven track record of identifying potential issues and proactively providing innovative solutions. This allows our clients to continue on the regulatory pathway and overcome obstacles.
Our team has extensive experience with the regulatory pathways involved in diagnostic lab services. We give clients the knowledge to anticipate future issues and remove barriers to regulatory approval. Whether it's supporting 510(k) submissions or Laboratory Developed Tests (LDT) for medical devices and diagnostic tests, our goal is to ensure your success and longevity.
InfinixBio works collaboratively with clients as a cross-functional disciplinary team, completing projects successfully within the agreed timeline and budget. This approach covers everything from discovery and proof of concept to preclinical testing, early clinical trials, and regulatory approval. We specialize in designing and conducting studies to support both 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests.
Our company excels at overcoming complex laboratory challenges, providing innovative solutions tailored to each client's needs. With extensive experience in drug discovery, pharmacology, and clinical diagnostics, we develop and test diagnostic assays, enabling successful 510(k) submissions. Our collaborative process involves working with various providers, including CROs, engineers, clinical labs, and device manufacturers.
Each client is assigned a team that includes a Project Manager who acts as a single point of contact. This structure facilitates fast responses and efficient problem-solving, minimizing risks and improving the overall responsiveness to client needs. Our scientists are proactive in identifying potential issues and devising solutions, allowing clients to maintain progress on regulatory pathways.
Designing, and testing diagnostic assays for 510(k) submissions involves several key steps in order to ensure compliance with FDA requirements. The design and development process starts with a proof of concept. Then the assay is built targeting a specific disease condition, followed by refinement based on the client’s needs.
From the very beginning of every project, special attention is given to tracking and maintaining assay development, collecting experimental data, and designing user-friendly protocols. These records are also useful for the design history file to support 510(k) submissions.
InfinixBio ensures a valid, and consistent process for our clients, by rigorously testing the developed assay under different conditions and samples.
InfinixBio has a wide variety of expertise with the diagnostic techniques like biomarker analysis, nucleic-acid based detection assays, PCR, antibody-based detection assays, and cell-based biosensors. Our scientists use these techniques to address the specific needs of each client.
The diagnostic product development and approval process typically requires the involvement of multiple companies, disciplines, and subject matter experts. InfinixBio performs key development work necessary for FDA approval and ensures a smooth technology transfer to other collaborators.
Yes, InfinixBio helps their clients with technology transfer. This involves providing hands-on training to the team of diagnostic labs, CLIA labs, and manufacturing partners.