Product Classification

• Device: leishmania spp. antigen detection assay
• Regulation Description: Trypanosoma spp. serological reagents.
• Definition: An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
• Physical State: In vitro diagnostic kit
• Technical Method: May include immunochromatographic assays, enzyme linked immunoassays, or other in vitro diagnostic methods to detect antigens from Leishmania spp.
• Target Area: Clinical specimens from patients suspected of infection with Leishmania spp.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PIT
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3870
• Device Class: 1
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc