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510(k) DEN060001

PHICAL TEST by Genova Diagnostics — Product Code NXO

DEN060001 is an FDA 510(k) premarket notification submitted by Genova Diagnostics for the device "PHICAL TEST". The FDA issued a decision of De Novo Granted on April 26, 2006. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 26, 2006
Date Received
March 23, 2006
Clearance Type
Post-NSE
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

  • K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap (February 6, 2024)
  • 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)
  • 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)

FDA data resources