MDCI: Guiding Innovation

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Medical Device Consultants, Inc. has assisted clients in meeting FDA and other international regulatory requirements for numerous in vitro diagnostics (IVDs) including:

In Vitro Diagnostics

• PCR Amplification and Detection System for Infectious Agent - strategy development including identification of testing requirements, critical review of all sections of 510(k) including non-clinical and clinical studies, assistance with preparation of 510(k)
• H. pylori Breath Test (analyzer and disposable) - strategy development, project management for complete 510(k) program including non-clinical and clinical studies, preparation of 510(k)s
• Cerebral Tissue Monitoring System (probe and accessories, analyzer and reagents) - strategy development, evaluation of technical documentation for IVD components of system, assistance with preparation of 510(k)
• Endotoxin Activity Assay (analyzer and reagents) - regulatory planning, critical review of all sections of PMA, assistance with preparation of modular PMA
• Cervical Cancer Screening System (analyzer and reagents) - strategy development, critical review of all sections of PMA including non-clinical and clinical studies, assistance with preparation of PMA
• Magnetic Microspheres for Ex Vivo Cell Purging and Enrichment - strategy development, evaluation of non-clinical and biocompatibility data, preparation of Master File submissions
• Immunoassays for Detection of Tumor-Associated Antigens (analyzer and reagents) – 510(k) and PMA strategy development, project management for all aspects of regulatory program including non-clinical and clinical studies for multiple assays
• Specimen Collection and Transport Devices (swabs and media) - evaluation of non-clinical studies data, preparation of 510(k)s
• CD4/CD8 Cell Monitoring System for HIV Status (analyzer and reagents) - strategy development, project management for complete 510(k) program including non-clinical and clinical studies, preparation of 510(k)
• Hematology and Immunology Systems (analyzer, reagents and controls) - strategy development, project management for all aspects of 510(k) program including non-clinical and clinical studies, preparation of 510(k)s
• Point-of-Care Devices for H. pylori and Hemoglobin Testing - strategy development including identification of non-clinical and clinical testing requirements, clinical trial monitoring and clinical data management, preparation of 510(k)s

In Vitro Diagnostics Case Study

A global company, based in Europe, with over 20 years of experience in developing, producing and marketing in vitro immunodiagnostic raw materials and diagnostic tests developed a qualitative immunochromatographic rapid test as an aid in the diagnosis of a serious complication in pregnant woman. The non-clinical and clinical data used to demonstrate the performance of this point-of-care test was generated outside of the United States. The company was concerned about its ability to use these data to support a 510(k) Premarket Notification submission to the FDA. MDCI was able to review and assess the data, prepare the 510(k) submission, and negotiate with the agency to achieve a successful 510(k) clearance without the need and related expense of additional U.S. based studies.

In Vitro Diagnostics Case Study #2

A global manufacturer of microbiology products developed a new and innovative system for the collection and transport of clinical specimens. One of the routine procedures in the diagnosis of bacteriological infections involves the collection and safe transportation of swab samples from the collection site to the testing laboratory. This new system incorporated a unique swab design to improve sample collection with a transport medium designed to sustain the viability of organisms during transit to the testing laboratory.

The company conducted multiple studies to evaluate the performance of the individual system components as well as complete collection kit formats. In addition, the company conducted extensive recovery studies to assess the viability of a wide range of bacteria during storage and use. All of this testing resulted in a significant amount of valuable data that needed to be reviewed and analyzed. MDCI was able to organize and present this large amount of data to effectively support the 510(k) submission and facilitate a very quick and efficient review by the FDA, resulting in 510(k) clearance in only 49 days.

Contact us for more information about in vitro diagnostic compliance and regulatory requirements.