ALPCO Calprotectin Immunoturbidimetric Assay
FDA 510(k) K220763 · Alpco
510(k) numberK220763
Submission
- Device name
- ALPCO Calprotectin Immunoturbidimetric Assay
- Applicant
- Alpco
Salem, NH, US - Received
- March 16, 2022
- Decision date
- April 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® CapNXO · Special | Bühlmann Laboratories AG | 02/06/2024SE |
| 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 |
More from Buhlmann Laboratories AG
| 510(k) | Device | Decision |
|---|---|---|
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXO · Traditional | 10/25/2019SE |
Questions and answers
When was ALPCO Calprotectin Immunoturbidimetric Assay cleared by the FDA?
ALPCO Calprotectin Immunoturbidimetric Assay (K220763) received a 510(k) decision of Substantially Equivalent on April 13, 2023, 393 days after the submission was received.
What is the product code of K220763?
The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.