• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device control, fecal occult blood
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 (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(K) Exempt
Regulation Number 864.6550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible