BÜHLMANN fCAL® turbo and CALEX® Cap
FDA 510(k) K232057 · Bühlmann Laboratories AG
510(k) numberK232057
Submission
- Device name
- BÜHLMANN fCAL® turbo and CALEX® Cap
- Applicant
- Bühlmann Laboratories AG
Schönenbuch, CH - Received
- July 11, 2023
- Decision date
- February 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K220763 | ALPCO Calprotectin Immunoturbidimetric AssayNXO · Traditional | Alpco | 04/13/2023SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | DiaSorin, Inc. | 07/26/2022SE |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXO · Traditional | Alpco | 10/25/2019SE |
| K191718 | Buhlmann fCAL turbo and CALEX CapNXO · Traditional | Buhlmann Laboratories AG | 09/24/2019SE |
| K191592 | CalprestNG, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K191589 | Calprest, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K190784 | BUHLMANN fCAL turboNXO · Traditional | Buhlmann Laboratories AG | 06/25/2019SE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional | DiaSorin, Inc. | 12/26/2018SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | Inova Diagnostics, Inc. | 10/16/2018SE |
| K181012 | BUHLMANN fCAL ELISANXO · Traditional | Buhlmann Laboratories AG | 06/04/2018SE |
Questions and answers
When was BÜHLMANN fCAL® turbo and CALEX® Cap cleared by the FDA?
BÜHLMANN fCAL® turbo and CALEX® Cap (K232057) received a 510(k) decision of Substantially Equivalent on February 6, 2024, 210 days after the submission was received.
What is the product code of K232057?
The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.