AutoGenomics' regulatory strategy is consistent with the company's overall mission and objectives: to offer an innovative and proprietary technology platform to clinical reference labs, specialty clinics and hospital laboratories.

AutoGenomics has developed instrumentation, reagents and applications that are at various stages of development and regulatory process:

To ensure product quality, AutoGenomics has established a quality system designed to meet the requirements of the FDA QSR and ISO 13485.

US

  • AutoGenomics has obtained 510(k) clearance for its INFINITI System Assay for Factor II, Factor V Leiden and Factor II/V Leiden.
  • AutoGenomics has obtained 510(k) clearance for its INFINITI Warfarin Assay.
  • AutoGenomics has obtained 510(k) clearance for its INFINITI CYP2C19 Assay.
  • AutoGenomics has submitted pre-IDE for its INFINITI HPV Screening Assay.
  • AutoGenomics has submitted pre-IDE for its INFINITI CFTR-31 Assay.
  • AutoGenomics has submitted pre-IDE for its INFINITI Flu A-sH1N1 Assay.
  • AutoGenomics is in the process of discussing premarket submissions strategies for several of its products with the FDA.

Canada

The following are licensed in Canada:

  • INFINITI Analyzer
  • INFINITI CYP2C19 Assay
  • INFINITI Warfarin Assay

International

AutoGenomics has obtained certification for ISO 13485 and CMDCAS (Canada).

In addition to the INFINITI Analyzer and the INFINITI Plus, AutoGenomics has CE-marked:

  • Warfarin Assay
  • CYP450 2C9-VKORC1
  • CYP2C19
  • CYP450 2C19+
  • CYP450 2D6I
  • Factor II
  • Factor V Leiden
  • MTHFR
  • Factor II-V Leiden
  • Factor II-V & MTHFR
  • CFTR-31
  • FMF
  • KRAS-BRAF
  • KRAS
  • BRAF
  • UGT1A1
  • HPV Genotyping
  • HPV QUAD
  • HPV-HR QUAD
  • RVP Plus
  • Flu A-sH1N1
  • UroGen QUAD
  • Bacterial Vaginosis QUAD
  • Candida Vaginitis QUAD

Regulatory Strategy