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Vysis EGR1 Fish Probe Kit - Sc

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN130010

by Abbott Molecular, Inc.

Identifiers

510(k) Number
DEN130010 FDA 510(k)
FDA Product Code
PDO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.1870 FDA 510(k)
Regulation Number
864.1870 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
DENG FDA 510(k)

The Vysis Egr1 Fish Probe Kit - Sc is an Early Growth Response Gene 1 (Egr1) Fish Probe Kit designed for specimen characterization. It detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens to characterize samples from patients with acute myeloid leukemia or myelodysplastic syndrome.

This assay is intended to be interpreted by a qualified pathologist and used alongside cytogenetics, morphology, and other clinical information to aid in determining prognosis at the time of diagnosis. The device is authorized under FDA 510K clearance. Users should refer to the specific product documentation for information regarding storage, handling, and clinical application.

Frequently asked questions

What is the primary clinical purpose of the Vysis Egr1 Fish Probe Kit - SC?

This kit is designed for specimen characterization by detecting the LSI EGR1 probe target on chromosome 5q. It is used in bone marrow specimens to help characterize samples from patients diagnosed with acute myeloid leukemia or myelodysplastic syndrome.

How should the results from this assay be utilized in a clinical setting?

The assay is intended to be interpreted by a qualified pathologist. Results should be used in conjunction with other clinical information, including cytogenetics and morphology, to assist in determining a patient's prognosis at the time of diagnosis.

What is the regulatory status of this device?

The Vysis Egr1 Fish Probe Kit - SC is authorized under FDA 510K clearance, identified by k-number DEN130010.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF vysis EGR1 FISH Probe Kit- SC (Specimen Characterization), PDF Vysis EGR1 FISH Probe Kit en - molecular.abbott, Vysis Egr1 Fish Probe Kit - Sc (Specimen Characterization)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Molecular, Inc.

Sources (1)

  • FDA 510(k) DEN130010 24 fields · synced Sep 21, 2026