# K972200: Aneuvysion

- Pathway: 510(k) (Traditional)
- Applicant: Vysis
- Decided: Oct 20, 1997 after 132 days
- Product code: OYU (Dna-Probe Kit, Human Chromosome)
- Device class: 2
- Regulation: 21 CFR 866.4700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The AneuVysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21922.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chrontosomes 13, 18, 21, X, and Y via flucrescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from uncultured amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for test reporting. 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. FISH results should not be re; prior to standard Cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard lf_::i\gngenetic results are not available, e.g., culture failure. Reporting and interpretafion of FISH should be consistent with professional standards of practice [1]. This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.

Source page: https://510kreport.com/device/K972200
Methodology: https://510kreport.com/methodology