Cleared Traditional

VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

K100015 · Abbott Molecular, Inc. · Pathology
Aug 2011
Decision
582d
Days
Class 2
Risk

About This 510(k) Submission

K100015 is an FDA 510(k) clearance for the VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34, a Chronic Lymphocytic Leukemia Fish Probe Kit (Class II — Special Controls, product code OVQ), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 9, 2011, 582 days after receiving the submission on January 4, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6040.

Submission Details

510(k) Number K100015 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2010
Decision Date August 09, 2011
Days to Decision 582 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OVQ — Chronic Lymphocytic Leukemia Fish Probe Kit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6040
Definition The Cll Fish Probe Kit Is Intended To Detect Deletion Of The Lsi Tp53, Lsi Atm, And Lsi D13s319 Probe Targets And Gain Of The D12z3 Sequence In Peripheral Blood Specimens From Untreated Patients With B-cell Chronic Lymphocytic Leukemia (cll). The Assay May Be Used To Dichotomize Cll (the 13q-, +12, Or Normal Genotype Group Versus The 11q- Or 17p- Group) And May Be Used As An Aid In Determining Disease Prognosis In Combination With Additional Biomarkers, Morphology And Other Clinical Information.