(60 days)
Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma. The Elecsys PSA assay is further indicated for serial measure of PSA to aid in the management of prostate cancer.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Bochringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37°C).
·1st incubation (9 minutes): Sample (40 µL), a biotinylated monoclonal PSA-specific antibody (60 uL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (60 uL) react to form a sandwich complex.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
•The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
Here's a breakdown of the acceptance criteria and the study information as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria | Elecsys 1010 Reported Performance | Elecsys 2010 (Predicate) Performance |
|---|---|---|
| Lower Detection Limit | 0.006 ng/mL | 0.002 ng/mL |
| Functional Detection Limit | 0.07 ng/mL | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (deviation ± 10%) | 0.01 - 100 ng/mL (deviation ± 10%) |
| Method Comparison (vs 2010) | y=0.9978x + 0.0040, r=0.9915 (Least Squares) | |
| y=0.9825x + 0.0935, r=0.9915 (Passing Bablock) | Not shown/Applicable | |
| Hook Effect | No Hook Effect up to 15,000 ng/ml PSA | No Hook Effect up to 15,000 ng/ml PSA |
| Intended Use | Immunoassay for in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma to aid in the management of prostate cancer patients. | Immunoassay for in vitro quantitative determination of prostate-specific antigen. The assay is further indicated for serial measurement of PSA to aid in the management of cancer patients. |
| Assay Range | 0-100 ng/ml | 0-100 ng/ml |
| Assay Methodology | Sandwich immunoassay | Sandwich immunoassay |
| Cross-Reactivity (to PAP) | 0% | 0% |
Note: The document explicitly states the Elecsys 1010 device is compared to the Elecsys 2010. The acceptance criteria for the Elecsys 1010 are implicitly defined by showing its performance in comparison to the already approved Elecsys 2010. For features like intended use, assay range, methodology, and cross-reactivity, the Elecsys 1010 is stated to be similar, implying these are directly met by mirroring the predicate. For performance metrics like detection limits and linearity, specific values are provided for both devices, and the method comparison data (Elecsys 1010 vs. Elecsys 2010) serves as the primary evidence of meeting similarity/equivalence.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Method Comparison: N=91
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions the comparison of the Elecsys 1010 to the Elecsys 2010.
3. Number of Experts and Qualifications for Ground Truth of the Test Set
- This information is not provided in the document. The study pertains to an in-vitro diagnostic device measuring PSA levels, not an imaging device or a device requiring human interpretation for its primary output. Therefore, expert consensus for ground truth is not typically applicable in the same way as for subjective diagnostic tasks.
4. Adjudication Method for the Test Set
- This information is not provided and is generally not applicable for a quantitative in-vitro diagnostic test where the "ground truth" is a measured analytical value. The method comparison uses statistical analysis (Least Squares and Passing Bablock regression) of quantitative results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- No, a MRMC study was not done. This type of study is relevant for scenarios where human readers interpret data (e.g., medical images) and an AI assists them. This document describes an automated in-vitro diagnostic device (PSA assay) where the output is a quantitative measurement, not interpreted by human readers in the same context.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done for the Elecsys 1010. The performance characteristics listed (Lower Detection Limit, Functional Detection Limit, Linearity, Hook Effect) are all measures of the device's intrinsic analytical performance when operating in a standalone capacity. The "Method Comparison" against the Elecsys 2010 also demonstrates the standalone performance against a predicate.
7. Type of Ground Truth Used
- The ground truth for the performance characteristics (detection limits, linearity, hook effect) would be established through analytical reference methods or certified reference materials to accurately define the true PSA concentration.
- For the "Method Comparison" study, the Elecsys 2010 immunoassay analyzer itself served as the reference/comparator for the Elecsys 1010 result, meaning the results from the Elecsys 2010 were treated as the comparative 'ground truth' for evaluating the Elecsys 1010's agreement.
8. Sample Size for the Training Set
- This information is not provided in the document. For an immunoassay, the "training set" would typically refer to the data used for developing and optimizing the assay reagents, calibration curves, and instrument parameters. The provided document focuses on the validation of the finalized device.
9. How the Ground Truth for the Training Set was Established
- This information is not provided in the document. Similar to point 8, the ground truth for an immunoassay's development/training phase would involve using well-characterized samples with known PSA concentrations, likely established through reference methods or certified materials, to ensure accurate calibration and assay performance optimization.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.