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U.S. Department of Health and Human Services

Product Classification
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Device chronic lymphocytic leukemia fish probe kit
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.
Physical State Reagents for B-cell chronic lymphocytic leukemia prognosis
Technical Method Fluorescent in situ hybridization
Target Area B-cell chronic lymphocytic leukemia
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeOVQ
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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