# DEN160003: Quantidex qPCR BCR-ABL IS Kit

- Pathway: De Novo (Direct)
- Applicant: Asuragen, Inc.
- Decided: Jul 22, 2016 after 185 days
- Product code: OYX (Bcr/Abl1 Monitoring Test)
- Device class: 2
- Regulation: 21 CFR 866.6060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (2019), 2 descendants of its own
- K252243: Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (2026), 0 descendants of its own
- K221869: BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (2023), 0 descendants of its own
- K190076: Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (2019), 0 descendants of its own

## Indications for use
The QuantideX qPCR BCR-ABL IS Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

Source page: https://510kreport.com/device/DEN160003
Methodology: https://510kreport.com/methodology