FDA product code OVQ: Chronic Lymphocytic Leukemia Fish Probe Kit
OVQ is the FDA product code for chronic lymphocytic leukemia fish probe kit. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under OVQ, from 2 different applicants. The average 510(k) review took 378 days (median 378). FDA has posted 1 recall for OVQ devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Chronic Lymphocytic Leukemia Fish Probe Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.6040 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OVQ clearance
Top OVQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 2011-08-09 |
| Vysis | 1 | 1997-01-13 |
Most recent OVQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100015 | Abbott Molecular, Inc. | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | 2011-08-09 | 582 |
| K962873 | Vysis | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | 1997-01-13 | 174 |
Recalls for OVQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-04.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code OVQ?
OVQ is the FDA product code for chronic lymphocytic leukemia fish probe kit. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel.
What device class is OVQ?
Class II, regulation 21 CFR 866.6040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVQ?
Across 2 cleared submissions the average was 378 days from receipt to decision (median 378).
Which companies have the most OVQ clearances?
Abbott Molecular, Inc. (1); Vysis (1).
Have OVQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code OVQ
- Run a recall and safety report across every OVQ manufacturer
- Watch product code OVQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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