510(k) · Cleared
ClearedVysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · OVQ Chronic Lymphocytic Leukemia Fish Probe Kit
Cleared on Aug 9, 2011 as substantially equivalent to DEN070009 (Agendia BV, 2007) after a 582-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Aug 9, 2011
- Review
- 582 days
- Class
- Class II
- Product code
- OVQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN070009 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN070009 MammaprintAgendia BV · 2007
- This deviceK100015 Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm…Abbott Molecular, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK091960 Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23…Abbott Molecular, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K091960Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green…Abbott Molecular, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| 0 (this device) | K100015 | Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and… | Abbott Molecular, Inc. | 2011 | — |
| +1 | K091960 | Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721… | Abbott Molecular, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN070009 | Mammaprint Our reading of the summary gave K062694, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070009, Mammaprint (Agendia BV), granted Feb 6, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091960 | Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green… | 2011 | 0 |
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?
How does its category compare?
All OVQ devicesOVQ Chronic Lymphocytic Leukemia 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 · OVQ
1in 2011
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vysis CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D1 3S319 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. The Vysis CLL FISH Probe Kit is not intended for use in selection of therapy or in monitoring of residual disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100015: Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100015
Report an extraction error
Are you the manufacturer?
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