OYX · Class II · 21 CFR 866.6060

FDA Product Code OYX: Bcr/abl1 Monitoring Test

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.

Leading manufacturers include Cepheid.

1
Total
1
Cleared
254d
Avg days
2019
Since

List of Bcr/abl1 Monitoring Test devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
K190076
Cepheid
Pathology · 254d

How to use this database

This page lists all FDA 510(k) submissions for Bcr/abl1 Monitoring Test devices (product code OYX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Pathology FDA review panel. Browse all Pathology devices →