510(k) Report

510(k) · Cleared

Cleared

Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green Probe), Model 4N37-020

K091960510(k) TraditionalCleared Aug 29, 2011789-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

Abbott Molecular, Inc. · OWK Early Growth Response 1 (Egr) Fish Probe Kit

Cleared on Aug 29, 2011 as substantially equivalent to K100015 (Abbott Molecular, Inc., 2011) after a 789-day review. Its family tree reaches back 2 generations to 2007.

Decided
Aug 29, 2011
Review
789 days
Class
Class II
Product code
OWK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to DEN070009 (2007). No later device cites it as a predicate yet.

DEN070009 · Mammaprint · Agendia BV · 2007K100015 · Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34 · Abbott Molecular, Inc. · 20112006200820102012
K100015 · Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34 · Abbott Molecular, Inc. · 2011DEN070009 · Mammaprint · Agendia BV · 20070
  1. Root · 2 generations backDEN070009 MammaprintAgendia BV · 2007
  2. 1 generation backK100015 Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm…Abbott Molecular, Inc. · 2011
  3. This deviceK091960 Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23…Abbott Molecular, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2DEN070009MammaprintAgendia BV2007—
−1K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and…Abbott Molecular, Inc.2011—
0 (this device)K091960Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721…Abbott Molecular, Inc.2011—
FIG. 1 — Lineage of K091960, 2007–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi…
Cleared while this submission was under review
Summary page 3
…Predicate Device(s) Similarities Item Device Predicate (k 1000 15) Intended Use Determination of deletion status as an Same aid in determining…
Abbott Molecular, Inc.2011—

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.

What does this lineage say?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All OWK devices

OWK Early Growth Response 1 (Egr) Fish Probe Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OWK

1in 2011

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

2026 to Oct 25, outlined.

Median 510(k) review, days · OWK

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

Recalls per year · OWK

No recall names OWK since 2007.

Adverse event reports per year · OWK

No MAUDE report names OWK since 2007.

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—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Vysis EGRI FISH Probe Kit is intended to detect deletion of the LSI EGRI probe target on chromosome Sq in bone marrow specimens and to be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome Sq has been associated with an unfavorable prognosis in AML patients.

Indications for use as stated in the FDA summary.

More from Abbott Molecular, Inc.

206 FDA decisions under this applicant name. See the company

https://510kreport.com/device/K091960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091960: Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green Probe), Model 4N37-020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091960

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026