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The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)

The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA).

This document is a 510(k) clearance letter from the FDA for a medical device (UBI MAGIWEL™ Opiates Metabolites). It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, etc.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This means the FDA reviewed data provided by the manufacturer (United Biotech, Inc.) to make the substantial equivalence determination, but the details of those studies are not present in this regulatory letter. To obtain that information, you would typically need to refer to the original 510(k) submission document itself, which is often not publicly available in full detail.

Therefore, I cannot provide the requested information based solely on the provided text.

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