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510(k) K190076

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems by Cepheid — Product Code OYX

K190076 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code OYX (Bcr/Abl1 Monitoring Test), a Class II device regulated under 21 CFR 866.6060. Cepheid has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2019
Date Received
January 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bcr/Abl1 Monitoring Test
Device Class
Class II
Regulation Number
866.6060
Review Panel
PA
Submission Type

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.

Other clearances by Cepheid

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)

Other clearances for product code OYX

  • K252243 — Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (July 2, 2026)
  • K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (September 5, 2023)
  • K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (February 13, 2019)
  • K173492 — MRDx BCR-ABL Test, MRDx BCR-ABL Test Software (December 22, 2017)
  • DEN160003 — Quantidex qPCR BCR-ABL IS Kit (July 22, 2016)

FDA data resources