Search Results
Found 1 results
510(k) Data Aggregation
(185 days)
Quantidex qPCR BCR-ABL IS Kit
The QuantideX qPCR BCR-ABL IS Kit 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) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument 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 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 QuantideX qPCR BCR-ABL IS Kit reagents are adapted for use on the ABI 7500 Fast Dx Real-Time PCR Instrument. The assay includes reagents sufficient for 60 reactions. A description of the reagents provided is described below in Table 1.
Here's a summary of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes both analytical and clinical performance acceptance criteria.
Analytical Performance - Precision/Reproducibility
| Performance Metric | Acceptance Criteria (SD) | Reported Device Performance (Max Total SD) | Met? |
|---|---|---|---|
| Within-lab Precision | |||
| MR Value 4.25 | ≤ 0.36 | 0.134 (at MR 4) | Yes |
| Site-to-Site Reproducibility | |||
| MR Value 4.25 | ≤ 0.36 | 0.167 (at MR 4) | Yes |
Analytical Performance - Linearity
| Performance Metric | Acceptance Criteria (Slope/Intercept for Regression) | Reported Device Performance (Slope/Intercept/Max SD) | Met? |
|---|---|---|---|
| Linear Regression | Slope close to 1 (not explicitly defined but implied typical regression expectations), intercept close to 0 (implied) | e13a2: Slope 1.01, Intercept -0.11, Max SD 0.17 | |
| e14a2: Slope 1.01, Intercept -0.05, Max SD 0.17 | Yes | ||
| Range of Linearity | (Implied based on clinical use range) | MR 0.3 (50% IS) to MR 4.7 (0.002% IS) for both transcripts | Yes |
Analytical Performance - Limit of Quantitation (LoQ)
| Performance Metric | Acceptance Criteria (SD) | Reported Device Performance (MR Range/SD Range) | Met? |
|---|---|---|---|
| LoQ | ≤ 0.36 at MR 4.5 or greater | MR values 4.6 to 4.87, SD values 0.23 to 0.34 | Yes |
Analytical Performance - Interfering Substances
| Performance Metric | Acceptance Criteria (Mean difference from control) | Reported Device Performance | Met? |
|---|---|---|---|
| Interference | Mean of test samples ± 0.5 MR of the control | All met acceptance criteria | Yes |
Analytical Performance - Primer Specificity
| Performance Metric | Acceptance Criteria | Reported Device Performance | Met? |
|---|---|---|---|
| Specificity | Specimens without a major BCR-ABL1 breakpoint reported as negative or below LoD in > 8/9 replicates | Met acceptance criteria (e.g., cell lines and IVT controls without e13a2/e14a2 were 95% of CML-negative samples tested negative or below LoD | All negative specimens (25/25) reported as "Negative (sufficient ABL1)" |
Analytical Performance - RNA Input
| Performance Metric | Acceptance Criteria (SD criteria from Table 3) | Reported Device Performance (RNA input range with met criteria) | Met? |
|---|---|---|---|
| RNA Input Range | Same as Table 3 for corresponding MR values | 750 to 6000 ng from MR 1 to MR 4.5 | Yes |
Analytical Performance - Traceability
| Performance Metric | Acceptance Criteria (Regression to WHO panel) | Reported Device Performance (Slope/Intercepts for 3 lots) | Met? |
|---|---|---|---|
| Traceability | Slope 1.0 to 1.1, Intercept 0.02 - 0.11 | Lot1: y=-0.11+1.1x; Lot2: y=0.02+1x; Lot3: y=-0.059+1.1x | Yes |
Analytical Performance - Specimen Stability (Whole Blood)
| Performance Metric | Acceptance Criteria (MR unit difference from baseline) | Reported Device Performance (Duration and storage conditions) | Met? |
|---|---|---|---|
| Whole Blood Stability | All results within 0.5 MR units from baseline | Up to 72 hours at 2-8°C | Yes |
Clinical Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance | Met? |
|---|---|---|---|
| Event-Free Survival (EFS) Difference at 36 months | Statistically significantly different AND point estimates differing by at least 10 percentage points (for MR 0 | Met | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The primary test set for clinical performance involved a retrospective study with:
- Sample Size: 137 evaluable samples from 96 subjects (out of 139 samples from 98 patients initially collected).
- Data Provenance: Retrospective, collected at 2 clinical sites in the US (OHSU and Hospital of the University of Pennsylvania).
For analytical performance studies, various sample compositions and quantities were used:
- Precision (within-lab & site-to-site): 25 samples formulated from 5 human RNA specimens positive for BCR-ABL1 diluted into RNAs from CML-negative blood. The site-to-site reproducibility study involved 1200 measurements from this 25-sample pool.
- Linearity/Reportable Range: 2 separate RNA specimens (one e13a2, one e14a2) diluted into RNAs from CML-negative whole blood (ranging from MR 0.1 to MR 4.8).
- Limit of Blank (LoB): 30 non-leukemic human RNA specimens.
- Limit of Detection (LoD): 4 separate human RNA specimens positive for BCR-ABL1, serially diluted to 28 levels.
- Limit of Quantitation (LoQ): 6 specimens derived from 6 human RNA positive for BCR-ABL (diluted to target MR 4.7).
- Interfering Substances: Residual CML-positive blood diluted to approximately MR 4.0 into RNA from CML-negative whole blood (tested in 9 replicates).
- Primer Specificity: 11 leukemic specimens (CML, AML, ALL) and 2 non-leukemic RNA specimens.
- Specimen Carryover Contamination: Serially diluted total RNA from residual clinical CML-positive blood into RNA from CML-negative whole blood in a checkerboard pattern (25 high positive, 25 negative).
- RNA Isolation: CML-positive white blood cells serially diluted across 4 levels (MR 1-4) into CML-negative human anti-coagulated whole blood.
- RNA Input: 30 samples derived from 2 primary RNA samples diluted into non-leukemic human RNA (total 216 evaluable observations).
- Traceability: WHO Reference Panel (4 panel members tested in duplicate).
- Reagent Stability: 5 samples diluted to approximately MR 1, 2, 3, 4, and
Ask a specific question about this device
Page 1 of 1