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U.S. Department of Health and Human Services

Product Classification

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Device bcr/abl1 quantitative monitoring test
Definition The bcr/abl1 quantitative 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 b2a2, b3a2 or e1a2 fusion transcripts.It is intended for use as an aid in the assessment of complete cytogenetic response (ccyr) and major molecular response (mmr).
Physical State Mulitplex quantitative chromosome translocation fusion transcript ratio amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA
Technical Method The test uses mulitplex reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) to detect and determine BCR-ABL1 (b2a2, b3a2 and e1a2) fusion transcript levels relative to levels of ABL1 transcript on a real-time PCR instrument.
Target Area Peripheral human whole blood or bone marrow
Review Panel Immunology
Product CodeOYX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
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