In response to the release of the November 2022 Abbott Point of Care customer letter (11-2022-168), which stated that the current version of the i-STAT cTnI cartridge is not FDA-cleared due to changes made to the product since 2003, the Centers for Medicare and Medicaid Services is exercising enforcement discretion (as of 12/08/2022).
Laboratories with a Certificate of Registration that applied for a Certificate of Compliance, or laboratories with a Certificate of Compliance, that have the i-STAT system, will continue to be allowed to use the cTnI test cartridge as a moderate complexity test.
Enforcement discretion will continue for the duration of the declared COVID-19 public health emergency or until the FDA has cleared/approved the changes to this test cartridge, whichever comes first. Laboratories need to follow all CLIA regulations that apply to moderate complexity testing.
Laboratories with a Certificate of Accreditation (CoA) are advised to contact their Accreditation Organization (AO) for specific guidance, as the AO may have more stringent requirements than those listed above.
