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U.S. Department of Health and Human Services

Product Classification

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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 CodeNXO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5180
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
Third Party Review Not Third Party Eligible
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