510(k) · Cleared

Cleared

Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna Probe

K962873510(k) TraditionalCleared Jan 13, 1997174-day reviewClass II21 CFR 866.6040

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

Vysis · OVQ Chronic Lymphocytic Leukemia Fish Probe Kit

Cleared on Jan 13, 1997 after a 174-day review. The FDA summary names no predicate by number.

Decided: Jan 13, 1997
Review: 174 days
Class: Class II
Product code: OVQ
Recalls: None
Predicates: 0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K962873Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OVQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All OVQ devices

OVQ Chronic Lymphocytic Leukemia Fish Probe Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OVQ

1in 2011

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	1
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (117 words)

The CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA. Probe Kit is designed to be an adjurict to standard cytogenetic analysis for in vitro diagrostic use in identifying and enumerating chromosome 12 via fluorescence in sifu hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with chronic lymphocytic leukemia (CLL). Results from the CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit are intended for use in conjunction with standard cytogenetics and for further assessing the trisomy 12 status in normal and abnormal tissue specimens characterized by standard cytogenetics, in patients with and/or without clinical symptoms of CLL. It is not intended to be a stand alone assay for test reporting.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962873: Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962873

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026