Home-Use Lab Tests
(also known as Over-The-Counter (OTC) Tests)

This section contains information about the on-line search for Home Use Lab Tests [Over-the-Counter tests (OTC)] and collection kits that have been cleared or approved by the FDA

• What Are Home-Use Tests
• How Can You Know If a Home-Use Test Is Regulated By FDA?

What Are Home-Use Tests?

Home-use tests are test kits that you use at home, without the help of healthcare professional. Most home-use tests are available over the counter (OTC) without a prescription.

There are two types of home-use tests: test kits and collection kits.

Test Kit: you take your own sample, test the sample, and read your own results.

Collection Kit: you take your own sample, mail it to a laboratory, and get your results over the phone or in the mail.

Home-use tests allow easy access to medical information about your health status. They can be cost-effective, quick, and confidential. Home tests can help:

1. detect possible health conditions when you have no symptoms, so that you can get early treatment and lower your chance of developing later complications (i.e. cholesterol testing, Hepatitis testing).
2. detect specific conditions when there are no signs so that you can take immediate action (i.e. pregnancy testing).
3. monitor conditions to allow frequent changes in treatment (i.e. glucose testing to monitor blood sugar levels in diabetes).

Despite the benefits of home testing, you should take precautions when using home-use tests. Home-use tests are intended to help you with your health care, but they should not replace periodic visits to your doctor. Many times, you should talk to your doctor even if you get normal test results. Most tests are best evaluated together with your medical history, a physical exam, and other testing. Always see your doctor if you are feeling sick, are worried about a possible medical condition, or if the test instructions recommend you do so.

See also: Home Diagnostic Tests: The Ultimate House Call?

How Can You Know If a Home-Use Test Is Regulated By FDA?

To find out if an over-the-counter home-use test is regulated by FDA, you can look for it in FDA's OTC database. This database contains information about over-the-counter products from 1977 to the present. It is updated monthly. To search the OTC database:

• Enter the name of the test in the first box. You may enter the entire name, but often the search is most successful when you enter just the first word or two, or just the first few letters.
• You do not need to enter any other information.
• Select Search at the bottom of the screen to submit your request.

  or

• Enter the name of the manufacturer in the second box.
• You do not need to enter any other information.
• Select Search at the bottom of the screen to submit your request.

  or

• Use the arrow key next to the “Test Type” box to select test type you are looking for.
• You do not need to enter any other information.
• Select Search at the bottom of the screen to submit your request.

  or

• To receive a list of the 500 most recently cleared OTC tests, leave all fields empty and select Search at the bottom of the screen to submit your request.

View the list you receive with the following reservations:

1. The brand names of the products or manufacturers may have changed since the devices were cleared.
2. Some of the devices may never have been sold or may not currently be sold.
3. Consumer information phone numbers for the older products may not be available or outdated.
4. The list does not include devices that may be available for prescription home use.

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If you still have a question about whether or not a particular home-use test is regulated by FDA, you can contact us.

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