Product Classification

• Device: gram-positive bacteria and their resistance markers
• Regulation Description: Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
• Definition: A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
• Physical State: blood
• Technical Method: Multiplexed DNA hybridization array
• Target Area: Systemic
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PAM
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3365
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 7-312 CLSI M39 5th Edition
  Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
• 7-322 CLSI M47 2nd Edition
  Principles and Procedures for Blood Cultures

Guidance Document

• Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures - Guideline for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible