# K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 13, 2019 after 233 days
- Product code: OYX (Bcr/Abl1 Monitoring Test)
- Device class: 2
- Regulation: 21 CFR 866.6060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082562 (2008). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160003: Quantidex qPCR BCR-ABL IS Kit, Asuragen, Inc. (2016) Summary page 4.
- K141220: Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software, Thermo Fisher Scientific (Life Technologies Holdin (2014) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Feb 15, 2024 · Class II · Z-1358-2024: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

## Indications for use
The QXDx™ 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 QXDx BCR-ABL %IS Kit is a reverse transcription-quantitative PCR performed on the Bio-Rad QXDx™ AutoDG™ ddPCR System 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 QXDx BCR-ABL %IS Kit is intended for use only on the Bio-Rad QXDx AutoDG ddPCR System. 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/K181661
Methodology: https://510kreport.com/methodology