510(k) K962873
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1997
- Date Received
- July 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chronic Lymphocytic Leukemia Fish Probe Kit
- Device Class
- Class II
- Regulation Number
- 866.6040
- Review Panel
- PA
- Submission Type
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.