Cleared Traditional

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

K962873 · Vysis · Pathology
Jan 1997
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K962873 is an FDA 510(k) clearance for the CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE, a Chronic Lymphocytic Leukemia Fish Probe Kit (Class II — Special Controls, product code OVQ), submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on January 13, 1997, 174 days after receiving the submission on July 23, 1996. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6040.

Submission Details

510(k) Number K962873 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1996
Decision Date January 13, 1997
Days to Decision 174 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.