Buhlmann fCAL turbo and CALEX Cap

FDA 510(k) K191718 · Buhlmann Laboratories AG

Substantially Equivalent

510(k) numberK191718

Submission

Device name
Buhlmann fCAL turbo and CALEX Cap
Applicant
Buhlmann Laboratories AG
Schönenbuch, CH
Received
June 26, 2019
Decision date
September 24, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NXO – Calprotectin, Fecal
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5180
Specialty
Immunology

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 510(k)s with product code NXO

510(k)DeviceApplicantDecision
K232057BÜHLMANN fCAL® turbo and CALEX® CapNXO · Special Bühlmann Laboratories AG02/06/2024SE
K220763ALPCO Calprotectin Immunoturbidimetric AssayNXO · Traditional Alpco04/13/2023SE
K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional DiaSorin, Inc.07/26/2022SE
K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXO · Traditional Alpco10/25/2019SE
K191592CalprestNG, EasyCalNXO · Special Eurospital S.P.A.07/10/2019SE
K191589Calprest, EasyCalNXO · Special Eurospital S.P.A.07/10/2019SE
K190784BUHLMANN fCAL turboNXO · Traditional Buhlmann Laboratories AG06/25/2019SE
K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional DiaSorin, Inc.12/26/2018SE
K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional Inova Diagnostics, Inc.10/16/2018SE
K181012BUHLMANN fCAL ELISANXO · Traditional Buhlmann Laboratories AG06/04/2018SE

More from Buhlmann Laboratories AG

510(k)DeviceDecision
K190784BUHLMANN fCAL turboNXO · Traditional 06/25/2019SE
K181012BUHLMANN fCAL ELISANXO · Traditional 06/04/2018SE
K954299Buhlmann Angiostensin II RiaCIB · Traditional 10/19/1995SE

Questions and answers

When was Buhlmann fCAL turbo and CALEX Cap cleared by the FDA?

Buhlmann fCAL turbo and CALEX Cap (K191718) received a 510(k) decision of Substantially Equivalent on September 24, 2019, 90 days after the submission was received.

What is the product code of K191718?

The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.