OYX · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 866.6060
Classification
FDA Product Code
OYX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6060
Review panel
PA
Medical specialty
Medical Genetics
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.