K190076 is an FDA 510(k) clearance for the Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems. This device is classified as a Bcr/abl1 Monitoring Test (Class II - Special Controls, product code OYX).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 27, 2019, 254 days after receiving the submission on January 16, 2019.
This device falls under the Pathology 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 | K190076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2019 |
| Decision Date | September 27, 2019 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| 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. |