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510(k) K220763

ALPCO Calprotectin Immunoturbidimetric Assay by ALPCO — Product Code NXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2023
Date Received
March 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calprotectin, Fecal
Device Class
Class II
Regulation Number
866.5180
Review Panel
IM
Submission Type

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.

Other clearances by ALPCO

  • K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (October 25, 2019)

Other clearances for product code NXO

  • K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap (February 6, 2024)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (October 25, 2019)
  • K191718 — Buhlmann fCAL turbo and CALEX Cap (September 24, 2019)
  • K191592 — CalprestNG, EasyCal (July 10, 2019)
  • K191589 — Calprest, EasyCal (July 10, 2019)
  • K190784 — BUHLMANN fCAL turbo (June 25, 2019)
  • K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Cal (December 26, 2018)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K181012 — BUHLMANN fCAL ELISA (June 4, 2018)