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510(k) K232057

BÜHLMANN fCAL® turbo and CALEX® Cap by Bühlmann Laboratories AG — Product Code NXO

K232057 is an FDA 510(k) premarket notification submitted by Bühlmann Laboratories AG for the device "BÜHLMANN fCAL® turbo and CALEX® Cap". The FDA issued a decision of Substantially Equivalent on February 6, 2024. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2024
Date Received
July 11, 2023
Clearance Type
Special
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 for product code NXO

  • K220763 — ALPCO Calprotectin Immunoturbidimetric Assay (April 13, 2023)
  • 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)
  • K191589 — Calprest, EasyCal (July 10, 2019)
  • K191592 — CalprestNG, 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)

FDA data resources