OVQ

Chronic Lymphocytic Leukemia Fish Probe Kit

Product code

OVQ

Device name

Chronic Lymphocytic Leukemia Fish Probe Kit

Device class

Class 2

21 CFR

21 CFR 866.6040

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).