Definition: 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
| Device Type ID | 3076 |
| Device Name | Calprotectin, Fecal |
| Physical State | N/a |
| Technical Method | Enzyme-linked Immunosorbent Assay (ELISA) |
| Target Area | N/a |
| Regulation Description | Fecal Calprotectin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5180 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NXO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3076 |
| Device | Calprotectin, Fecal |
| Product Code | NXO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fecal Calprotectin Immunological Test System. |
| CFR Regulation Number | 866.5180 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BUHLMANN LABORATORIES AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EUROSPITAL S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |