Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OYX · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
254 daysmedian FDA review time
434 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026-07-02 | 349 | 0 |
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023-09-05 | 434 | 0 |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity | Cepheid | 2019-09-27 | 254 | 1 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019-02-13 | 233 | 1 |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | 2017-12-22 | 39 | 0 |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Asuragen, Inc. | 2016-07-22 | 185 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda