# K100015: Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Aug 9, 2011 after 582 days
- Product code: OVQ (Chronic Lymphocytic Leukemia Fish Probe Kit)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN070009 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN070009: Mammaprint, Agendia BV (2007). 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.

## Most influential descendants
- K091960: Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green Probe), Model 4N37-020 (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100015
Methodology: https://510kreport.com/methodology