Food and Drug Administration Categorization Notification for McKesson Consult Immunochemical Fecal Occult Blood Test

Attention:  Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals

Please share this announcement with the following:

  • Medical Director, Laboratory Services
  • Administrative Director and Managers, Laboratory Services

On May 4, 2018, the Food and Drug Administration published notice for McKesson Consult Immunochemical Fecal Occult Blood Test.”

Key Points:

Regulations codified at 42 CFR 493.15 et. seq., implementing the Clinical Laboratory Improvement Amendments of 1988, require the Secretary to provide for the categorization of specific clinical laboratory test systems by the level of complexity. Based upon these regulations, on May 4, 2018, the Food and Drug Administration (FDA) approved the McKesson Consult Immunochemical Fecal Occult Blood Test, CR180283, k171484, as a waived complexity test under CLIA for fecal occult blood.  Waived status is applicable to the test system and their instructions approved by the FDA.  The FDA recommended that the test system instructions include a statement that the test is waived under CLIA.

This complexity categorization is effective as of the date of this notification and will be reported in FDA’s CLIA Database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Are any AOA/HFAP Standards affected by this change?

No. This notice is provided for your information only.

Effective date:  Immediately