Home / 510(k) Clearances / K221869

510(k) K221869

BCR-ABL1 (p210) % IS Kit (Digital PCR Method) by Suzhou Sniper Medical Technologies Co., Ltd. — Product Code OYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2023
Date Received
June 28, 2022
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 for product code OYX

  • K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert I (September 27, 2019)
  • 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)