OVQClass II

Chronic Lymphocytic Leukemia Fish Probe Kit

21 CFR 866.6040 / Immunology

OVQ is the FDA product code for Chronic Lymphocytic Leukemia Fish Probe Kit, a class II device type, regulated under 21 CFR 866.6040. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2011-08-09, and one recall.

Classification record

Product code: OVQ
Device name: Chronic Lymphocytic Leukemia Fish Probe Kit
FDA 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.
Regulation: 21 CFR 866.6040
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 1

Clearances, product code OVQ

By decision year

2 clearances under product code OVQ with a decision year between 1997 and 2011, 1997 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OVQ by decision year
Year	Clearances
1997	1
2011	1

Applicants with the most clearances

Product code OVQ

Applicants holding the most 510(k) clearances under product code OVQ
Applicant	Clearances
Abbott Molecular, Inc.	1
Vysis	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Abbott Molecular, Inc.

Recent clearances

Product code OVQ

Recent recalls

Product code OVQ

Z-2576-2021Class IIPotential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.Abbott Molecular, Inc. / initiated 2021-08-04 / 186 units

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About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)