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FDA-cleared/approved tests

Assays cleared (510k), approved (PMA), or exempted by the United States Food and Drug Administration (FDA) that have not been modified to change the procedure or the intended use. FDA clearance or approval status can be found at FDA's Medical Devices website. A separate FDA site lists Approved Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays. This includes Investigational Use Only (IUO)-labeled tests ONLY when utilized under a specific FDA Investigational Device Exemption (IDE).

Apply using the eCLEP application on the Health Commerce System (HCS)


        For Genetic Testing – Molecular tests, please refer to this Guidance document


  1. Laboratories applying for an initial permit may include FDA-approved assays on the test list included in the initial permit application; no additional forms are necessary.
  2. Laboratories holding a permit in the required category may perform FDA-approved assays once they have filed the Add/Delete analyte form and have met their own quality management systems requirements.
  3. Laboratories applying for a category (please refer to Permit Category Descriptions), or applying for an initial permit, may begin testing once the permit has been amended or issued. Verification data will be reviewed during the initial survey (for new permits and categories) or during the next on-site survey (for laboratories already holding a permit).
  4. The Department may, based on survey findings or other concerns about the performance of the assay, request additional documentation and verification data. Refer to requirements in the Clinical Laboratory Standards of Practice (Examination Practices Validation/VAL S5).