Chronic Lymphocytic Leukemia Fish Probe Kit
The Chronic Lymphocytic Leukemia FISH Probe Kit (product code OVQ) is an in vitro diagnostic test 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) using fluorescence in situ hybridization (FISH). The assay may be used to dichotomize CLL into prognostic groups and is used as an aid in determining disease prognosis in combination with additional biomarkers and clinical information. As an FDA Class 2 device under regulation 866.6040, it requires 510(k) premarket clearance and falls within the Immunology specialty, reviewed by the Pathology panel. The device is eligible for third-party review and is not an implant or life-sustaining.
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Basic Information
- Product Code
- OVQ
- Device Class
- FDA class 2
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | Aug 09, 2011 | Substantially Equivalent | Abbott Molecular, Inc. |
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | Jan 13, 1997 | Substantially Equivalent | Vysis |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.