Medical Devices

How You Can Get the Best Results With Home Use Tests

Follow the tips listed here to use home-use tests as safely and effectively as possible.

  • Read the label and instructions carefully. Review all instructions and pictures carefully to make sure you understand how to perform the test. Be sure you know:
    • what the test is for and what it is not for
    • how to store the test before you use it
    • how to collect and store the sample
    • when and how to run the test, including timing instructions
    • how to interpret the test
    • what might interfere with the test
    • the manufacturer's phone number if you have questions
  • Use only tests regulated by FDA.
    There are several ways to find out if FDA regulates a home-use test. You can ask your pharmacist or the vendor selling the test. If FDA does not regulate the test, the U.S. government has not determined that the test is reasonably safe or effective, or substantially equivalent to another legally marketed device.
  • Follow all instructions. You must follow all test instructions to get an accurate result. Most home tests require specific timing, materials, and sample amounts. You should also check the expiration dates and storage conditions before performing a test to make sure the components still work correctly.
  • Keep good records of your testing.
  • Call the "800" telephone number listed on your home-use test if you have any questions.
  • When in doubt, contact your doctor. All tests can give false results. You should see your doctor if you believe your test results are wrong.
  • Don't change medications or dosages based on a home-use test without talking to your doctor.

Page Last Updated: 12/28/2017
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