510(k) K010288
K010288 is an FDA 510(k) premarket notification submitted by Vysis for the device "ANEUVYSION MULITICOLOR DNA PROBE KIT". The FDA issued a decision of Substantially Equivalent on April 13, 2001. The device falls under product code OYU (Dna-Probe Kit, Human Chromosome), a Class II device regulated under 21 CFR 866.4700. Vysis has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2001
- Date Received
- January 31, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Probe Kit, Human Chromosome
- Device Class
- Class II
- Regulation Number
- 866.4700
- Review Panel
- PA
- Submission Type
Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.