Definition: The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.
| Device Type ID | 2436 |
| Device Name | Automated Occult Blood Analyzer |
| Physical State | The System Consists Of An Analyzer, Test Reagents (antibody, Calibrators And Controls) And Collection Devices Containing Buffer. |
| Technical Method | The Test Reagent Contains An Immunoassay Utilizing Monoclonal And Polyclonal Antibodies For Human Hemoglobin. A Light Beam Measures The Antibody Reaction, I.e. The Absorbance Fo The Reaction Mixture Measures The Concentration Of Hemoglobin In The Spe |
| Target Area | Fecal Samples |
| Regulation Description | Occult Blood Test. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.6550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2436 |
| Device | Automated Occult Blood Analyzer |
| Product Code | OOX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Occult Blood Test. |
| CFR Regulation Number | 864.6550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BODITECH MED INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |