Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k) K190076 · Cepheid
Submission
- Device name
- Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- January 16, 2019
- Decision date
- September 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYX – Bcr/Abl1 Monitoring Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6060
- Specialty
- Medical Genetics
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…
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|---|---|---|---|
| K252243 | Fastplex BCR-ABL (p210) %IS digital PCR KitOYX · Traditional | Suzhou Precigenome, Ltd. Co; | 07/02/2026SE |
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method)OYX · Traditional | Suzhou Sniper Medical Technologies Co., Ltd. | 09/05/2023SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | Bio-Rad Laboratories, Inc. | 02/13/2019SE |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test SoftwareOYX · Traditional | Molecularmd Corporation | 12/22/2017SESD |
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Questions and answers
When was Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems cleared by the FDA?
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076) received a 510(k) decision of Substantially Equivalent on September 27, 2019, 254 days after the submission was received.
What is the product code of K190076?
The FDA product code is OYX – Bcr/Abl1 Monitoring Test, a Class II (moderate risk) device regulated under 21 CFR 866.6060.