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510(k) Data Aggregation
(510 days)
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.
The NADiA® ProsVue™ assav is not intended for the diagnosis or for the monitoring of prostate cancer.
ProsVue™ is a two-site immunoassay utilizing an assay specific synthetic DNA sequence as a label with a PCR detection method. Calibrators, controls and samples react with a reagent containing a monoclonal PSA-specific antibody labeled with an assay-specific double-stranded DNA sequence. Then a reagent of paramagnetic microparticles coupled to a monoclonal antibody specific for another site on PSA is added and allowed to react to form a specific sandwich complex with PSA. After washing the particles to remove reactants, a reagent containing a heat-stable polymerase, specific primers, nucleotides, and a fluorescent dye is added to the washed microparticles. An Applied Biosystems® (AB) 7500 Fast Dx Real-Time PCR instrument is utilized to detect the presence of the monoclonal PSA-specific antibody labeled with an assay specific DNA sequence indicating the levels of PSA in the samples. PSA values of controls and samples are calculated in pg/mL from a calibrator dose-response plot. ProsVue slope is calculated using ProsVue Software from the calculated PSA concentrations of three patient samples collected between six weeks and 20 months post radical prostatectomy.
The assay is made up of Reporter Antibody Reagent, Target Capture Reagent. PCR Reagent, Calibrators, Directions for Use (DFU) and ProsVue Software. Wash Reagent, Sample Diluent, and a three-level assayed control set are provided separately. ProsVue users initially receive the DFU and ProsVue software, which provide instructions and quality control support for the process of sample scheduling, collection and storage. When samples are ready for testing, the user contacts Iris Molecular Diagnostics (IMD), and IMD ships the required reagents.
Here's a breakdown of the acceptance criteria and study details for the NADiA® ProsVue™ device, based on the provided text:
Acceptance Criteria and Device Performance
The document describes pre-specified performance characteristics and then presents the results of the studies conducted. It does not explicitly state "acceptance criteria" as a separate, quantitative table for clinical performance. Instead, it describes performance with results that demonstrate the device's capability. For analytical performance, the limits are established, and the device is shown to meet them.
Table of Performance Metrics and Reported Values
| Performance Metric | Acceptance Criteria (Implied / Stated Limits) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Measuring Interval | N/A - but defined as the range the device can measure. | 0.65 pg/mL to 100 pg/mL |
| Limit of Blank (LOB) | Determined with CLSI EP17-A guideline. | 0.17 pg/mL |
| Limit of Detection (LOD) | Determined with CLSI EP17-A guideline. | 0.27 pg/mL |
| Limit of Quantitation (LOQ) | Determined with CLSI EP17-A guideline. | 0.65 pg/mL |
| Linearity | Deviation from linearity less than 24% from 0.65 pg/mL to 100 pg/mL. | Deviation from linearity less than 24% from 0.65 pg/mL to 100 pg/mL. |
| Total Variation (%CV) (Precision) | N/A - but demonstrated across low, intermediate, and high samples. | Low Sample: 15.2% |
| Intermediate Sample: 9.4% | ||
| High Sample: 10.6% | ||
| Between-lot Imprecision | Not more than 4.0% | Not more than 4.0% |
| Interference (Blood Const.) | Less than 10% interference in assay results at specified concentrations. | Less than 10% interference at tested concentrations. |
| Interference (Drugs) | Less than 10% interference in assay results at specified concentrations. | Less than 10% interference at tested concentrations. |
| PSA Stability | Stability projections: 99.6% and 99.7% immunoreactive at 20 years at -70°C. | Met these projections based on accelerated stability study. |
| Reagent/Control Shelf Life | Defined by control recovery within limits over time. | Kit, Calibrators, PCR Reagent: 41 days |
| Controls: 78 days | ||
| Target Capture, Reporter Antibody: 41 days | ||
| Wash Solution: 41 days | ||
| Sample Diluent: 41 days | ||
| Clinical Performance | ||
| Kaplan-Meier 8-year Probability of "Stable" (Slope ≤ 2 pg/mL/month) | N/A - but demonstrated to be high. | 95.9% (95% CI: 93.4 - 98.4%) |
| Kaplan-Meier 8-year Probability of "Stable" (Slope > 2 pg/mL/month) | N/A - but demonstrated to be low. | 37.3% (95% CI: 25.0 - 49.6%) |
| Univariate Cox HR (Slope > 2 vs. ≤ 2) | N/A - but demonstrated to be a significant predictor. | HR = 18.3 (95% CI: 10.6 to 31.8; p 2 vs. ≤ 2) |
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