From the FDA web site:A 510(k) is a premarket submission made to...

From the FDA web site:

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, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

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A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:

- resubmit another 510(k) with new data,
- request a Class I or II designation through the de novo process
- file a reclassification petition, or
submit a premarket approval application (PMA).



SBN are asking the FDA to approve the use of Oraline based on the fact that it is substantially equivalent to current approved FDA products. The current FDA approved products are urine based. My feeling is that the FDA will give a NSE (Not Substantially Equivalent) ruling because the Oraline test is very much differnt to current FDA approved urine testing products. I'm not too sure about urine based tests but do they test for the 4 drugs that Oraline does?

If they do get a NSE ruling then the only two options open to them are the de nove process or a PMA (Pre Market Approval) application. The de novo process asks the FDA to lower the risk rating from a class III to a class I or II. The PMA application is a much more long winded and stringent process.

BTW I note that in April 2007 they received an FDA warning for their urine based tests resulting in them being taken off the market. In an ASX ann on August 1, 2007 they said they were filing a 510(k) application for their urine based tests so they could recomence marketing of these devices once FDA approval is received. I have yet to see any ann on the ASX regarding the approval from the FDA of their urine based tests. If they have not yet received FDA approval for VisuaLine after 6 months, I wouldn't be holding my breath for Oraline approval soon.

Welcome any other information anyone has on the FDA application for VisuaLine or OraLine.