510(k) Report

FDA product code · Pathology

Chronic Lymphocytic Leukemia Fish Probe Kit

OVQClass II21 CFR 866.6040510(k) required2 decisions since 19970 recalls

2 FDA decisions since 1997. No recall names this code. The most-cited predicate is K100015, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, pathology panel

Twenty years of OVQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OVQ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVQ

Too few OVQ 510(k)s in any year since 2007 to give a median.

Recalls per year · OVQ

No recall names OVQ since 2007.

Adverse event reports per year · OVQ

1in 2021

2016: 12021: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code OVQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OVQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OVQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OVQ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319…Abbott Molecular, Inc. · 20111cites it

Which OVQ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319…Abbott Molecular, Inc. · 20111generation

What has FDA decided in OVQ lately?

  • K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319…Abbott Molecular, Inc. · 2011
  • K962873Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna ProbeVysis · 1997

All 2 OVQ decisions →

Related product codes

Other codes under 21 CFR 866.6040.

OWM Prostate-Specific Antigen (Psa) For…NYI Classifier, Prognostic, Recurrence Risk…OWK Early Growth Response 1 (Egr) Fish Probe Kit