Product Classification

• Device: phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates
• Regulation Description: Antimicrobial susceptibility test powder.
• Definition: Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
• Physical State: Single use, disposable
• Technical Method: Biochemical hydrolysis
• Target Area: Not applicable
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PTJ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1640
• 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

Third Party Review

Not Third Party Eligible