; and (bb) immediately prior to such date of enactment was exempt pursuant to subsection (l) or (m)(2) of section 510 from the requirements for submission of a report under section 510(k); or (II) (aa) was not offered for clinical use prior to such date of enactment; (bb) is not an instrument; and (cc) falls within a category of tests that was exempt from the requirements for submission of a report under section 510(k) as of such date of enactment (including class II devices and excluding class I devices described in section 510(l)); (ii) meets the applicable standard as described in section 587(2); (iii) is not offered with labeling and advertising that is false or misleading