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510(k) K213858

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

K213858 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus". The FDA issued a decision of Substantially Equivalent on July 26, 2022. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)
  • K201908 — LIAISON Testosterone xt (October 15, 2020)

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)

FDA data resources