K221869 is an FDA 510(k) clearance for the BCR-ABL1 (p210) % IS Kit (Digital PCR Method). This device is classified as a Bcr/abl1 Monitoring Test (Class II - Special Controls, product code OYX).
Submitted by Suzhou Sniper Medical Technologies Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 5, 2023, 434 days after receiving the submission on June 28, 2022.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.6060. A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value..
| 510(k) Number | K221869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2022 |
| Decision Date | September 05, 2023 |
| Days to Decision | 434 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| Summary | Summary PDF |
| Product Code | OYX - Bcr/abl1 Monitoring Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6060 |
| Definition | A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value. |