Cleared Traditional

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

K091960 · Abbott Molecular, Inc. · Pathology
Aug 2011
Decision
789d
Days
Class 2
Risk

About This 510(k) Submission

K091960 is an FDA 510(k) clearance for the VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020, a Early Growth Response 1 (egr) Fish Probe Kit (Class II — Special Controls, product code OWK), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 29, 2011, 789 days after receiving the submission on July 1, 2009. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6040.

Submission Details

510(k) Number K091960 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2009
Decision Date August 29, 2011
Days to Decision 789 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OWK — Early Growth Response 1 (egr) Fish Probe Kit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6040
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.