Product Classification

• Device: early growth response 1 (egr) fish probe kit
• Regulation Description: Gene expression profiling test system for breast cancer prognosis.
• Definition: The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.
• Physical State: Device is a kit containing labeled FISH Probes
• Technical Method: Detection of Early Growth Response Gene (EGR1) by fluorescence in-situ hybridization.
• Target Area: Not applicable
• Regulation Medical Specialty: Immunology
• Review Panel: Pathology
• Product Code: OWK
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 866.6040
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc