Requirements for Waived Tests To receive a certificate of waiver...

Requirements for Waived Tests

To receive a certificate of waiver under CLIA, a lab must only perform tests like the glucose meter test which the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined to be so simple that there is little risk of error.
http://www.cms.gov/Regulations-and-...ertificate_of_-Waiver_Laboratory_Project.html

For a device to be waived from CLIA
accreditation, it must only perform a
simple test with minimal risk for an incorrect
result that could alter patient care.
Manufacturers may apply for a CLIA waiver
for their device when the system can be
used by patients at their own homes

http://www.alfascientific.com/news-events/clia-waived-testing-explained
What Is CLIA?
Often we are asked by distributors why it is important for a test to be CLIA-Waived. Well to answer that question it is first best to explain what CLIA stands for. The Clinical Laboratory Improvement Amendments of 1988 specifies that laboratory requirements must be based on the complexity of the test performed. As a result they established provisions for categorizing a test as Waived.
If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.
Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.
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Now, after reading from the horses mouth, tell me that FDA will allow a CLIA waiver for the use of POC troponin tests for cardiac management.