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510(k) K170993

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer by Inova Diagnostics, Inc. — Product Code NXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2017
Date Received
April 3, 2017
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

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  • 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)