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 Chromo
| Device Type ID | 4927 |
| Device Name | Bcr/abl1 Monitoring Test |
| Physical State | Multiplex Quantitative RT-PCR Assay To Detect Chromosome Translocation Fusion Transcripts And Control Transcripts Test System. |
| Technical Method | The Test Uses Multiplex Reverse–transcriptase Polymerase Chain Reaction To Detect And Determine BCR-ABL1 (such As E13a2 And/or E14a2) Fusion Transcript Levels And Quantifies Them Relative To Levels Of ABL1 Transcript (or Other Validated Control Gene) |
| Target Area | Peripheral Human Whole Blood Or Bone Marrow. |
| Regulation Description | BCR-ABL Quantitation Test. |
| Regulation Medical Specialty | Molecular Genetics |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4927 |
| Device | Bcr/abl1 Monitoring Test |
| Product Code | OYX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | BCR-ABL Quantitation Test. |
| CFR Regulation Number | 866.6060 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASURAGEN, INC. | ||
GRANTED | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MOLECULARMD CORPORATION | ||
SUBSTANTIALLY EQUIVALENT - WITH DRUG | 1 | |