K110345 is an FDA 510(k) clearance for the SCANVIEW SYSTEM. Classified as System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (product code NTH), Class II - Special Controls.
Submitted by Applied Spectral Imaging (Haifa, IL). The FDA issued a Cleared decision on October 19, 2011 after a review of 257 days - an extended review cycle.
This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.
NCT01264744
Completed
Observational
Industry-sponsored
Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)
Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections
| Condition studied |
Bladder Cancers |
| Eligibility |
All sexes
|
| Principal investigator |
Sheila - Dobin, Ph.D. |
| Sponsor |
Applied Spectral Imaging Ltd.
(industry)
|
Started 2009-11-01
→
Primary completion 2010-08-01
Study completed - no results published.
This trial concluded in 2010 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov