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U.S. Department of Health and Human Services

Product Classification

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Device control, fecal occult blood
Regulation Description Occult blood test.
Definition Fecal occult blood controls (negative and positive) are used to verify the performance of the fecal occult blood test devices.
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 according to the manufacturer's instructions. The negative control produces one distinct color band in the control area and the positive control produces two color bands in the control and the test area of the lateral flow strips of the test device.
Target Area Occult blood in human stool.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeOSL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.6550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible