Product Classification

• Device: reagent, borrelia serological reagent
• Regulation Description: Treponema pallidum treponemal test reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LSR
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3830
• 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

• 7-180 CLSI M34-A (Replaces M24-P)
  Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.

Guidance Document

• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible