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.

5
Total
4
Cleared
229d
Avg days
2016
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Bcr/abl1 Monitoring Test Devices (Product Code OYX)

5 devices
1–5 of 5
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
K190076
Cepheid
Pathology · 254d

About Product Code OYX - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code OYX since 2016, with 4 receiving FDA clearance (average review time: 229 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

OYX devices are reviewed by the Pathology panel. Browse all Pathology devices →