Is OncuraKit FDA-approved or FDA-cleared?

No — OncuraKit is NOT FDA-approved or FDA-cleared. It is a Laboratory Developed Test (LDT) analyzed at a CLIA-certified laboratory. Under current FDA regulations, LDTs are generally not required to undergo FDA pre-market review before clinical use. The FDA has historically exercised enforcement discretion over most LDTs, acknowledging the long history of LDTs as a standard pathway for innovative clinical testing. OncuraKit is not registered with the FDA as an In Vitro Diagnostic (IVD) device. It is not listed in the FDA's 510(k) database. It is not on the FDA's PMA-approved device list. We are transparent about this regulatory status because accuracy is fundamental to trust. Offering a test as an LDT under CLIA certification is a legitimate, well-established regulatory pathway used by thousands of clinical tests in the United States.