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, Suzhou Sniper Medical Technologies Co., Ltd. and Bio-Rad Laboratories, Inc..
6
Total
5
Cleared
249d
Avg days
2016
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
349d
recently vs 229d historically
FDA 510(k) Cleared Bcr/abl1 Monitoring Test Devices (Product Code OYX)
6 devices
Cleared
Sep 05, 2023
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
Suzhou Sniper Medical Technologies Co., Ltd.
Medical Genetics
434d
Cleared
Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
Cepheid
Pathology
254d
Cleared
Feb 13, 2019
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Bio-Rad Laboratories, Inc.
Medical Genetics
233d
About Product Code OYX - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code OYX since 2016, with 5 receiving FDA clearance (average review time: 249 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OYX Product Code
Recent submissions under OYX have taken an average of 349 days to reach a decision - up from 229 days historically. Manufacturers should account for longer review timelines in current project planning.
OYX devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →