Definition: Fecal Occult Blood Controls (Negative And Positive) Are Used To Verify The Performance Of The Fecal Occult Blood Test Devices.
| Device Type ID | 2439 |
| Device Name | Control, Fecal Occult Blood |
| Physical State | The Control Solutions Are In The Aqueous Form. |
| Technical Method | The Test Is Based On The Detection Of Human Hemoglobin. The Negative Control Solution Contains Only Buffer. The Positive Control Solution Contains Human Hemoglobin At A Specified Concentration. The Control Solution Is Placed In The Test Device Accord |
| Target Area | Occult Blood In Human Stool. |
| Regulation Description | Occult Blood Test. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.6550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |