510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYXClass II

Bcr/Abl1 Monitoring Test

21 CFR 866.6060 / Medical Genetics
FDA source (opens on fda.gov)

OYX is the FDA product code for Bcr/Abl1 Monitoring Test, a class II device type, regulated under 21 CFR 866.6060. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
OYX
Device name
Bcr/Abl1 Monitoring Test
FDA 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.
Regulation
21 CFR 866.6060
Device class
Class II
Review panel
Medical Genetics
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
3

Clearances, product code OYX

By decision year
6 clearances under product code OYX with a decision year between 2016 and 2026, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OYX by decision year
YearClearances
20161
20171
20192
20231
20261

Applicants with the most clearances

Product code OYX
Applicants holding the most 510(k) clearances under product code OYX
ApplicantClearances
Asuragen, Inc.1
Bio-Rad Laboratories Inc.1
Cepheid1
Molecularmd Corporation1
Suzhou Precigenome, Ltd. Co1
Suzhou Sniper Medical Technologies Co., Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code