CalprestNG, EasyCal
FDA 510(k) K191592 · Eurospital S.P.A.
510(k) numberK191592
Submission
- Device name
- CalprestNG, EasyCal
- Applicant
- Eurospital S.P.A.
Trieste, IT - Received
- June 14, 2019
- Decision date
- July 10, 2019
- 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 |
|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® CapNXO · Special | Bühlmann Laboratories AG | 02/06/2024SE |
| 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 |
| 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 |
More from Buhlmann Laboratories AG
Questions and answers
When was CalprestNG, EasyCal cleared by the FDA?
CalprestNG, EasyCal (K191592) received a 510(k) decision of Substantially Equivalent on July 10, 2019, 26 days after the submission was received.
What is the product code of K191592?
The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.