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U.S. Department of Health and Human Services

Product Classification

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Device bcr/abl1 monitoring test
Definition 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.
Physical State Multiplex quantitative RT-PCR assay to detect chromosome translocation fusion transcripts and control transcripts test system.
Technical Method The test uses multiplex reverse–transcriptase polymerase chain reaction to detect and determine BCR-ABL1 (such as e13a2 and/or e14a2) fusion transcript levels and quantifies them relative to levels of ABL1 transcript (or other validated control gene). The test may utilize other technologies and/or quantification methods.
Target Area Peripheral human whole blood or bone marrow.
Regulation Medical Specialty Molecular Genetics
Review Panel Pathology
Product CodeOYX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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