Intended Use

The Vysis D7S486/CEP 7 FISH Probe Kit is a device intended for specimen characterization and detects the LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe target on chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The

assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this device for diagnosis, prognosis, monitoring, or risk assessment has not been established.

Limitations of the Procedures

• For In Vitro Diagnostic Use
• The Vysis D7S486/CEP 7 FISH Probe Kit is intended to be used in combination with additional biomarkers, morphology, and other clinical information.
• Other atypical signal patterns may occur, and metaphase analysis may be helpful in characterization of such patterns.
• If a specimen has an overall low signal intensity FISH pattern and a low level of cells with an atypical (1R2G and/or 1R1G) FISH signal pattern, use of the appropriate single pass filter to confirm the pattern is recommended. Failure to follow this recommendation may result in inaccurate identification of signals.

CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.