Tests - Professional or Home Use (Glucose Meters, Etc.)

How do we know if a particular waived test or instrument, such as a glucose meter, is approved for professional use?  

Any examples are for illustrative purposes only.

Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.

To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the 510(k) summary that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/

Follow the following steps to determine if the test is intended for professional use:
  1. Enter the name of the device in the search field.
  2. Locate the device in the list produced by the search.
  3. Click on the "Summary" for the device to open the 510(k) document.
  4. Read the 510(k) summary, particularly the section titled "Intended Use".
  5. If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Last updated on March 18, 2020
Manual: Home Care
Chapter: Waived Testing WT

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