DeviceClearance

Product code OYX— Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

Classification name
Bcr/Abl1 Monitoring Test
Device class
Class 2
Regulation
21 CFR 866.6060
Advisory panel
Medical Genetics
Total cleared
6
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OYX under 21 CFR 866.6060, via openFDA

Market context for product code OYX

FDA has cleared 6 devices under product code OYX between 2016 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OYX

Recent clearances under product code OYX

Data sourced from openFDA. This site is unofficial and independent of the FDA.