In Vitro Diagnostics

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In Vitro Diagnostic Devices

Aptiv Solutions is a leader in addressing FDA and European IVDD (IVD Directive) regulatory and clinical trial requirements for in vitro diagnostic devices. Our experience includes work on more than 120 IVD projects, ranging from traditional IVD assays to molecular diagnostics, and IVDMIAs.

Infectious Disease

  • ELISA assay for identification of Borrelia burgdorferi (Lyme disease) – performance testing review , 510(k) preparation and submission
  • Point of care and laboratory diagnostics for detection of sexually transmitted diseases – FDA regulatory strategy, development and conduct of supporting clinical studies, 510(k) preparation and submission
  • 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
  • PCR amplification and detection system for infectious agent – strategy development including identification of in vitro diagnostic testing requirements, critical review of all sections of 510(k) including non-clinical and clinical studies, assistance with preparation of 510(k)
  • 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)
  • Independent positive and negative controls for infectious disease testing QC/QA – regulatory strategy, Canadian License application preparation and submission

Oncology

  • Genetic markers for detection of lung , colorectal, and bladder cancers – Regulatory strategy, pre IDE meeting activities
  • Companion diagnostic for colorectal cancer – interlab validation study, including site selection, clinical monitoring, database development, and data management
  • Melanoma detection – Regulatory strategy / CLIA review
  • Breast cancer diagnostic – clinical site audits, training and site management
  • 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 for this in vitro diagnostic
  • 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

Cardiovascular

  • Cardiac inflammation-marker – regulatory strategy, pre IDE activities, general consulting
  • ELISA assay for aid in diagnosing congestive heart failure (CHF) – regulatory strategy, labeling review, quality system activities, 510(k) preparation and submission
  • Diagnostic tools for management of cardiovascular risk factors – 510(k) review and guidance
  • Cardiac damage biomarker – US and EU study management and monitoring

Clinical Laboratory Test Systems, Reagents and Instrumentation

  • 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 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
  • Analyzer and test system for detection of gynecological conditions – FDA regulatory strategy, labeling review, software review, 510(k) preparation and submission
  • Automated gene expression test system – FDA regulatory strategy, pre-IDE activities
  • Molecular diagnostic test for single and multiplexed nucleic acid amplification assay – FDA regulatory strategy development
  • Specimen collection and transport swabs and media – evaluation of non-clinical studies data, preparation of 510(k)s
  • DNA probe-based system for quantitative detection of specific nucleic acid sequences – clinical data management

Other

  • Cerebral Tissue Monitoring System (probe and accessories, analyzer and reagents) – strategy development, evaluation of technical documentation for IVD (in vitro diagnostic) 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
  • Genotyping assays for smoking cessation/IVD MIA – FDA regulatory strategy, pre IDE meeting

IVD Case Studies

Women’s Health Diagnostic Test

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 in vitro diagnostic 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. Aptiv Solutions 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.

Sample Collection and Transport System

A global manufacturer of microbiology products including in vitro diagnostic devices 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. Our team 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.