(67 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 measurement of PSA to aid in the management of cancer patients.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer 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 (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.
•2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), 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-generated by 2-point calibration and a master curve provided via the reagent bar code.
Here's an analysis of the provided text regarding the Elecsys® PSA on Elecsys 1010, focusing on acceptance criteria and the supporting study:
The document is a 510(k) summary for the Elecsys® PSA Assay on the Elecsys 1010 analyzer. It seeks to establish substantial equivalence to the same assay run on the Elecsys 2010. The study presented is a method comparison study.
Acceptance Criteria and Reported Device Performance:
The document implicitly uses the performance of the predicate device (Elecsys® PSA on Elecsys 2010) as the de facto acceptance criteria for the new device (Elecsys® PSA on Elecsys 1010). The goal is to demonstrate that the performance characteristics of the Elecsys 1010 system are comparable to the Elecsys 2010 system.
| Feature | Predicate Device (Elecsys 2010) Acceptance Criteria (Implicit) | Elecsys 1010 Reported Performance |
|---|---|---|
| Sensitivity | ||
| Analytical | 0.002 ng/mL (Reference performance) | 0.006 ng/mL |
| Functional | 0.03 ng/mL (Reference performance) | 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (deviation from linear line of ±10%) | 0.01 - 100 ng/mL (deviation from linear line of ±10%) |
| Method Comparison | Not explicitly stated as an acceptance criterion, but the performance of y=x is implicitly desired | Least Squares: y = 0.9948x - 0.0642; r = 0.996; N = 154 |
| Passing Bablok: y = 0.9965x + 0.0112; r = 0.996; N = 154 | ||
| Hook Effect | No Hook Effect up to 17,000 ng/ml PSA | No Hook Effect up to 17,000 ng/ml PSA |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: 154 samples were used for the method comparison study.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic device (immunoassay for PSA levels), not an imaging or diagnostic AI device where human experts establish ground truth for a test set.
- The "ground truth" for the test set in this context is the measurement obtained from the predicate device (Elecsys 2010).
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Adjudication method for the test set:
- Not applicable. As this is an in vitro diagnostic device comparing its results to a predicate device, there is no adjudication process involving multiple human readers for a test set in the traditional sense.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of images or other complex data. This submission is for an automated immunoassay.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is essentially a standalone algorithm performance study. The Elecsys® PSA assay on the Elecsys 1010 operates as an automated system, and its performance is evaluated directly against the predicate device. There is no human "in the loop" in generating the raw quantitative PSA result, though the result would be interpreted by a clinician.
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The type of ground truth used:
- The "ground truth" for the method comparison study is the results obtained from the predicate device, the Elecsys® PSA Assay on the Elecsys 2010 analyzer. The objective is to show agreement between the new device and the predicate.
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The sample size for the training set:
- This being a 510(k) for an immunoassay, the concept of a "training set" for an AI model's ground truth is not directly applicable. The assay itself is a chemical and mechanical process, not a machine learning algorithm that learns from data.
- However, the calibration of the Elecsys 1010 (and 2010) involves a 2-point calibration and a master curve provided via the reagent bar code. The data used to establish these calibration curves and the assay parameters would be analogous to a "training" process in a broader sense, but no sample size for this is provided.
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How the ground truth for the training set was established:
- Again, the typical "ground truth for training set" framework for AI is not applicable here.
- For the immunoassay, the "ground truth" for calibration and assay development would have been established through a rigorous process of using reference materials, certified calibrators, and possibly comparison to established reference methods (though not detailed in this summary). This process ensures the accuracy and reliability of the assay's measurements.
§ 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.