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

Xpert BCR-ABL Ultra

Name: Xpert BCR-ABL Ultra
Brand: Xpert BCR-ABL Ultra

Xpert BCR-ABL Ultra measures BCR-ABL1 RNA relative to ABL RNA in peripheral blood from patients with diagnosed Philadelphia chromosome positive chronic myeloid leukemia. It monitors…

Registry build 21.09.26

Xpert BCR-ABL Ultra measures BCR-ABL1 RNA relative to ABL RNA in peripheral blood from patients with diagnosed Philadelphia chromosome positive chronic myeloid leukemia. It monitors patients expressing e13a2 or e14a2 fusion transcripts during tyrosine kinase inhibitor treatment. The test reports results on the International Scale.

After initial sample preparation, a disposable cartridge runs on a compatible GeneXpert system. The instrument performs additional nucleic acid preparation, reverse transcription and quantitative real time PCR. Results include the BCR-ABL to ABL percentage and a molecular response value.

Listed Item

Xpert BCR-ABL Ultra test; 10 test kit

Test Scope

The assay does not distinguish between the two supported fusion transcript types and does not monitor other rare fusion transcripts. It is intended for monitoring and is not a test for diagnosing chronic myeloid leukemia.

1manufacturer

1catalogue number

1510(k) clearance

2recalls on this code

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 Xpert BCR-ABL Ultra
Listed by	Cepheid, United States
FDA product code	OYX
Device type	Bcr/Abl1 Monitoring Test
Device class	Class 2
Regulation	21 CFR 866.6060
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
510(k)	K190076
Record published	2019-10-25
Record revised	2020-10-06 (version 2)

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 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Xpert BCR-ABL Ultra
Catalogue number	Size	Status
GXBCRABL-US-10		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MRDx BCR-ABL Test	Molecularmd Corporation	1
QuantideX qPCR BCR-ABL IS Kit	Asuragen, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190076	2019-09-27

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Xpert BCR-ABL Ultra
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Cepheid	510(k) number	2025-10-30	Class II	Process design	Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.	6325 units

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-10-30	Class II	Process design	Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.	4032 units

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.