Cleared Traditional

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

K173492 · MolecularMD Corporation · Pathology
Dec 2017
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K173492 is an FDA 510(k) clearance for the MRDx BCR-ABL Test, MRDx BCR-ABL Test Software, a Bcr/abl1 Monitoring Test (Class II — Special Controls, product code OYX), submitted by MolecularMD Corporation (Portland, US). The FDA issued a Cleared decision on December 22, 2017, 39 days after receiving the submission on November 13, 2017. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6060.

Submission Details

510(k) Number K173492 FDA.gov
FDA Decision Cleared SESD
Date Received November 13, 2017
Decision Date December 22, 2017
Days to Decision 39 days
Submission Type Traditional
Review Panel Pathology (PA)
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.