# K091960: Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green Probe), Model 4N37-020

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Aug 29, 2011 after 789 days
- Product code: OWK (Early Growth Response 1 (Egr) 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: 2 generations back to DEN070009 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100015: Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi D135319 Spectrumorange/13Q34, Abbott Molecular, Inc. (2011). Cleared while this submission was under review Summary page 3.

## Indications for use
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.

Source page: https://510kreport.com/device/K091960
Methodology: https://510kreport.com/methodology