What is FDA product code OYX?

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.

Immunology & Microbiology › Tumor Antigen Test SystemsBcr/Abl1 Monitoring Test

MRDx BCR-ABL Test

Name: MRDx BCR-ABL Test
Brand: MRDx BCR-ABL Test

The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both…

Registry build 21.09.26

The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both reverse transcription and quantitative PCR reactions to be performed in the same well. This provide the advantage of increase sensitivity while limiting experimental variables and also reducing time and cost. The MRDx BCR-ABL Test uses BCR-ABL and ABL standard curves to determine BCR-ABL and ABL copy numbers. The assay has been harmonized to the WHO primary standards for determination of Major Molecular Response (MMR) levels based on the International Scale (IS). Major Molecular Response (MMR) or MR3, defined as greater than or equal to a 3-log reduction in the ration of BCR-ABL/ABL from a standardized baseline value, reflects a patient’s response to treatment. In addition, the MRDx BCR-ABL Test includes MR4.5 to enable quantification to 0.0032% IS, which is greater than a 4-log reduction, important for treatment discontinuation and for monitoring of treatment-free remission.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OYX
Manufacturer	City	Province	Registered as	Device types
Suzhou Sniper Medical Technologies Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4

Record

Regulatory record for MRDx BCR-ABL Test
Listed by	Molecularmd Corporation, United States
FDA product code	OYX
Device type	Bcr/Abl1 Monitoring Test
Device class	Class 2
Regulation	21 CFR 866.6060
Establishment	Complaint-file establishment, Manufacturer
510(k)	K173492
Record published	2018-03-07
Record revised	2020-10-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -85 to -15 °C

Catalogue Numbers

Catalogue numbers for MRDx BCR-ABL Test
Catalogue number	Size	Status
901-0028		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QuantideX qPCR BCR-ABL IS Kit	Asuragen, Inc.	1
Xpert BCR-ABL Ultra	Cepheid	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K173492	2017-12-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.