Cleared Traditional

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

K181661 · Bio-Rad Laboratories, Inc. · Medical Genetics
Feb 2019
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K181661 is an FDA 510(k) clearance for the QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, a Bcr/abl1 Monitoring Test (Class II — Special Controls, product code OYX), submitted by Bio-Rad Laboratories, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 13, 2019, 233 days after receiving the submission on June 25, 2018. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.6060.

Submission Details

510(k) Number K181661 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2018
Decision Date February 13, 2019
Days to Decision 233 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF

Device Classification

Product Code OYX — Bcr/abl1 Monitoring Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6060
Definition A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value.