MRDx BCR-ABL Test
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Basic Information
- Brand Name
- MRDx BCR-ABL Test
- Primary DI
- B60290100280
- Version / Model
- 901-0028
- Catalog Number
- 901-0028
- Company Name
- MOLECULARMD CORP.
- Labeler DUNS
- 784311032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-07
- Public Version
- 3
- Public Version Date
- 2020-10-06
- Public Version Status
- Update
- Public Device Record Key
- 99642795-6c90-4012-adca-5328544658ba
Device Description
The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both reverse transcription and quantitative PCR reactions to be performed in the same well. This provide the advantage of increase sensitivity while limiting experimental variables and also reducing time and cost. The MRDx BCR-ABL Test uses BCR-ABL and ABL standard curves to determine BCR-ABL and ABL copy numbers. The assay has been harmonized to the WHO primary standards for determination of Major Molecular Response (MMR) levels based on the International Scale (IS). Major Molecular Response (MMR) or MR3, defined as greater than or equal to a 3-log reduction in the ration of BCR-ABL/ABL from a standardized baseline value, reflects a patient's response to treatment. In addition, the MRDx BCR-ABL Test includes MR4.5 to enable quantification to 0.0032% IS, which is greater than a 4-log reduction, important for treatment discontinuation and for monitoring of treatment-free remission.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OYX | Bcr/Abl1 Monitoring Test | Medical Genetics | 866.6060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44431 | Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Philadelphia chromosome, resulting from translocation t(9;22)(q34; q11) and rearrangement of the BCR and ABL genes, to diagnose, monitor or predict chronic myeloid leukaemia (CML) and/or a subset of acute lymphoblastic leukaemia (ALL) in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B60290100280 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173492 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -85 – -15 Degrees Celsius