Product Classification

• Device: calprotectin, fecal
• Regulation Description: Fecal calprotectin immunological test system.
• Definition: The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
• Physical State: n/a
• Technical Method: Enzyme-linked immunosorbent assay (ELISA)
• Target Area: n/a
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: NXO
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5180
• 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

Guidance Documents

• Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems.

• Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems; Availability.

• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc