Product Classification

• Device: test, factor v leiden mutations, genomic dna pcr
• Regulation Description: Factor V Leiden DNA mutation detection systems.
• Definition: In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Product Code: NPQ
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 864.7280
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-237 CLSI MM01-A3 (Replaces MM01-A2)
  Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition

Guidance Document

• Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible