MainPercent of 510(k) In Vitro Diagnostics (IVD) decision summaries posted on the web within the 45 day timeframe during the monthA 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 a Premarket Approval (PMA). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency (SE) claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.This measure quantifies OIVD’s ability to inform the public about devices cleared through the 510(k) process. Expedient posting of review memos will provide up to date information to the public.Percentline20100100TargetFY 2010 Overall: 93%20110100TargetFY 2011 Overall: 94%01002012FY 2012 YTD: 92%SubPercent of 510(k) In Vitro Diagnostics (IVD) decision summaries posted on the web within the 45 day timeframe during the monthNumber of IVD decision summaries posted within 45 day timeframe during the monthNumbercolumn2010060TargetFY 2010 Total: 2862011060TargetFY 2011 Total: 3090602012FY 2012 YTD: 165SubPercent of 510(k) In Vitro Diagnostics (IVD) decision summaries posted on the web within the 45 day timeframe during the monthTotal number of IVD decision summaries posted during the monthNumbercolumn2010060TargetFY 2010 Total: 3082011060TargetFY 2011 Total: 3280602012FY 2012 YTD: 179http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htmFDA-TRACK CDRH Dashboard਍††਍਍਍਍਍਍਍