Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

I believe that even though the Lactoferrin test appears to have been updated as a Class 1 test, possibly on December 22nd, 2023, it seems that AXIM still has the requirement to go through the CoW process (Certificate of Waiver).

Cut/Pasted from the FDA CLIA Waiver Application website.

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application



A manufacturer of a test initially categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. When a test is categorized as waived, it allows that test to be performed by laboratories with a Certificate of Waiver (CoW) or a Certificate for Provider Performed Microscopy (PPM) in addition to the other CLIA Certificate types. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3). The statute states that:

"The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver] are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly."