# K252243: Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Precigenome, Ltd. Co;
- Decided: Jul 2, 2026 after 349 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
Longest line of descent: 3 generations back to K082562 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, Bio-Rad Laboratories, Inc. (2019) Summary page 10.

## Indications for use
The Fastplex™ BCR-ABL (p210) % IS digital PCR 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 Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is a reverse transcription-quantitative PCR performed on the RainSure DropMDx digital PCR 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 Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is intended for use only on the RainSure DropMDx digital PCR 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/K252243
Methodology: https://510kreport.com/methodology