Keyword Analysis & Research: 510k vs clia

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What is a 510 (k) submission?

A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices...

What is the difference between complicated and waived tests Under CLIA?

In general, the more complicated the test, the more stringent the requirements under CLIA. Laboratories or sites that perform only waived tests only need to follow the manufacturer’s instructions for those tests to meet CLIA requirements.

What are the CLIA standards for ppm tests?

Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M. PPM procedures are certain moderate complexity microscopy tests commonly performed by health care providers during patient office visits.

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