{"entity":{"id":"digital-pcr-platforms","kind":"technology","name":"Digital PCR and BCR::ABL1 monitoring kits (QXDx, Fastplex, Xpert BCR-ABL Ultra)","aka":["Digital PCR","Droplet digital PCR","ddPCR","QXDx","BCR-ABL monitoring","International Scale","Xpert BCR-ABL Ultra","Quantidex"],"tldr":"Tests that count copies of a cancer gene in a blood sample, used most in chronic myeloid leukaemia to measure how far the BCR::ABL1 signal has fallen on treatment. Digital PCR splits the sample into thousands of droplets and counts the positive ones.","summary":"The FDA created product code OYX for BCR::ABL1 monitoring tests (21 CFR 866.6060) with Asuragen's Quantidex qPCR BCR-ABL IS kit (De Novo DEN160003, 22 July 2016). Bio-Rad's QXDx BCR-ABL %IS kit on the QXDx AutoDG ddPCR system (K181661, 13 February 2019) measures BCR::ABL1 to ABL1 on the International Scale \"in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors\" and \"is not intended for the diagnosis of CML\". Digital PCR kits from China followed: Suzhou Sniper Medical's BCR-ABL1 (p210) %IS kit (K221869, 5 September 2023) and Suzhou Precigenome's Fastplex (K252243, 2 July 2026). Cepheid's Xpert BCR-ABL Ultra on GeneXpert (K190076, 27 September 2019) is a cartridge quantitative PCR test. The droplet digital PCR instrument itself has its own code, PHG (21 CFR 862.2570).","status":"established","asOf":"2026-11-04","links":[{"label":"FDA product code OYX: BCR/ABL1 monitoring test","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=OYX"},{"label":"FDA De Novo DEN160003: Quantidex qPCR BCR-ABL IS kit","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160003"},{"label":"FDA 510(k) K181661: QXDx BCR-ABL %IS kit (13 February 2019)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181661"},{"label":"FDA 510(k) K221869: Sniper BCR-ABL1 (p210) %IS digital PCR kit (5 September 2023)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221869"},{"label":"FDA 510(k) K252243: Fastplex BCR-ABL (p210) %IS digital PCR kit (2 July 2026)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252243"},{"label":"FDA 510(k) K190076: Xpert BCR-ABL Ultra (27 September 2019)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190076"},{"label":"FDA product code PHG: droplet digital PCR system","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=PHG"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["cml"],"sections":["diagnostics","devices"],"technologies":["liquid-biopsy","flow-cytometers","haematology-analysers"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"The sample is partitioned into thousands of droplets or wells so each holds zero or a few target molecules; after PCR, the fraction of positive partitions gives an absolute count by Poisson statistics without a standard curve.","strengths":["Absolute quantification sensitive enough for deep molecular response","Reported on the International Scale for CML"],"limitations":["Cleared kits cover common transcripts only (e13a2, e14a2)","Not for diagnosis"],"since":2016},"route":"/technologies/digital-pcr-platforms/","neighbours":{"cancer":[{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"flow-cytometers","kind":"technology","name":"Flow cytometers","route":"/technologies/flow-cytometers/"},{"id":"haematology-analysers","kind":"technology","name":"Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio)","route":"/technologies/haematology-analysers/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}]}}