# K131508: Vysis D7S486/Cep 7 Fish Probe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Sep 13, 2013 after 112 days
- Product code: PFG (Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders)
- Device class: 2
- Regulation: 21 CFR 864.1870
- 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 DEN130010 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130010: Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization), Abbott Molecular, Inc. (2013). Our reading of the summary gave K123951, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130010, Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization) (Abbott Molecular, Inc.), granted Jul 29, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The Vysis D7S486/CEP 7 FISH Probe Kit is a device intended for specimen characterization, and detects the LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe target on chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this device for diagnosis, prognosis, monitoring, or risk assessment has not been established.

Source page: https://510kreport.com/device/K131508
Methodology: https://510kreport.com/methodology