K181661 is an FDA 510(k) clearance for the QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System. This device is classified as a Bcr/abl1 Monitoring Test (Class II - Special Controls, product code OYX).
Submitted by Bio-Rad Laboratories, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 13, 2019, 233 days after receiving the submission on June 25, 2018.
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 | K181661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2018 |
| Decision Date | February 13, 2019 |
| Days to Decision | 233 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. |