Search Results
Found 1 results
510(k) Data Aggregation
(434 days)
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t (9;22) positive Chronic Myeloid Leukemia (CML) adult patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is a reverse transcription-quantitative PCR performed on the Sniper Digital PCR All-in-One System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t (9:22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is intended for use only on the Sniper Digital PCR All-in-One System.
The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t (9:22). This test is not intended for the diagnosis of CML.
The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is designed for detection of the BCR-ABL1 fusion gene (p210) and ABL1 gene, with specific primers and specific fluorescence probes. The test process includes three parts. The first part is to extract ribonucleic acid (RNA) from peripheral blood of CML patients. The second part is to detect BCR-ABL1 fusion gene (p210) and ABL1 internal reference gene in RNA samples by RT-dPCR (Reverse Transcription-Droplet PCR) reaction solution using the Sniper Digital PCR All-in-One System (DQ24-Dx). The third part is to analyze the results.
The Sniper Digital PCR All-in-One System consists of one instrument, which can be used together with it's supporting consumables and BCR-ABL1 (p210) %IS Kit (Digital PCR Method) to complete the detection of samples.
The Sniper Digital PCR All-in-One System divides the sample into about 20000 droplets and carries out PCR amplification, read the number of positive and negative droplets through fluorescent signals, and then calculate the concentration of nucleic acid quantitatively according to the volume of the droplets and the principle of Poisson Distribution.
DQ24-Dx-Sight Software (v1.0.2) is used to control the system and analyze test results. This software is embedded in the Sniper Digital PCR All-in-One System.
Here's a breakdown of the acceptance criteria and study detailed in the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision (CV, %) requirements for MR values in multi-site study: | All acceptance criteria for precision were satisfied. |
| - MR0.3-MR2.0: ≤ 10% | - MR1.0 (e13a2, e14a2, mix): Total CV% range 1.85% - 2.38% |
| - MR2.1-MR3.49: ≤ 15% | - MR2.0 (e13a2, e14a2, mix): Total CV% range 1.54% - 1.82% |
| - MR3.5-MR4.0: ≤ 20% | - MR3.0 (e13a2, e14a2, mix): Total CV% range 2.37% - 3.11% |
| - LOQ: ≤ 20% | - MR4.0 (e13a2, e14a2, mix): Total CV% range 2.31% - 3.43% |
| - MR4.5 (e13a2, e14a2, mix): Total CV% range 4.95% - 5.68% | |
| Controls & Calibrators Precision (CV, %) in multi-site study: | Calibrators 10%IS MR CV: 2.10%, %IS CV: 5.00% |
| Calibrators 0.1%IS MR CV: 1.79%, %IS CV: 12.20% | |
| Positive control 1 MR CV: 2.14%, %IS CV: 5.18% | |
| Positive control 2 MR CV: 2.68%, %IS CV: 23.86% | |
| Precision (CV, %) requirements for MR values in batch-to-batch study: | All acceptance criteria for batch-to-batch precision were satisfied. |
| - MR0.3-MR2.0: 0.95. | Intercept A (95% CI): 0.17 (0.13-0.22), Slope B (95% CI): 0.99 (0.97-1.01). Spearman correlation coefficient: 0.988 (P |
Ask a specific question about this device
Page 1 of 1