# K221869: BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Sniper Medical Technologies Co., Ltd.
- Decided: Sep 5, 2023 after 434 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 4.

## Indications for use
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) 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) adult patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is a reverse transcription-quantitative PCR performed on the Sniper Digital PCR All-in-One 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 BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is intended for use only on the Sniper Digital PCR All-in-One 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/K221869
Methodology: https://510kreport.com/methodology