(132 days)
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 21q22.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chromosomes 13, 18, 21, X, and Y via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from 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 reported prior to standard cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard cytogenetic results are not available, e.g., culture failure. Reporting and interpretation of FISH should be consistent with professional standards of practice! 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.
The AneuVysion™ kit is a combination of two DNA probe mixtures; CEP 18/X/Y and LSI 13/21. The CEP 18/X/Y probe is a mixture of directly labeled fluorescent DNA probes specific for the D18Z1, DXZ1 and DYZ3 regions of chromosomes 18, X, and Y respectively. The LSI 13/21 probe contains a mixture of unique DNA sequences that hybridize in the 13q14 region of chromosome 13, and unique DNA sequences complementary to the D21S259, D21S341, and D21S342 loci contained within the 21q22.13 to 21q22.2 region on the long arm of chromosome 21. The LSI 13 probe was created from a set of overlapping clones which contain the entire RB-1 gene as well as regions extending beyond the gene on both sides. The probe extends beyond the 180 kb RB-1 gene for 110-170 kb in the 5' direction and approximately 120 kb in the 3' direction; the entire probe is 410-470 kb. CEP 18/X/Y is an aqua, green, and orange tri-color probe mixture and LSI 13/21 is a green and orange dual-color probe mixture.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hybridization Efficiency |
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.