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Clarification Regarding the Use of Control Materials as Calibrators to Determine Test Cut-off Values
Guidance for Controls as Calibration Materials. Controls provided by manufacturers in a test kit are considered to be calibration materials if they are used to calculate the cutoff value of a test or a patient test result.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: September 29, 2017
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.