510(k) K213858

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus by DiaSorin, Inc. — Product Code NXO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 26, 2022
Date Received: December 10, 2021
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.

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Other clearances for product code NXO

K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap (February 6, 2024)
K220763 — ALPCO Calprotectin Immunoturbidimetric Assay (April 13, 2023)
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)