(218 days)
OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.
OPUS PSA is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of prostate specific antigen (PSA) in human serum.
Behring Diagnostics Inc. OPUS® PSA 510(k) Notification (K964595)
The Behring Diagnostics Inc. OPUS® PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in human serum. It is intended as an adjunctive test to aid in the monitoring of prostate cancer patients.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Intra-assay) | Not explicitly stated (implied by acceptable %CV) | %CV ranged from 5.1% to 5.8% |
| Precision (Inter-assay) | Not explicitly stated (implied by acceptable %CV) | %CV ranged from 6.6% to 7.0% |
| Accuracy (by Recovery) | Not explicitly stated (implied by acceptable % recovery) | Percent recovery ranged from 97% to 107% |
| Accuracy (by Correlation) | Not explicitly stated (implied by acceptable correlation coefficient, y-intercept, and slope compared to a legally marketed device) | Correlation coefficient of 0.98, y-intercept of 0.36, and slope of 0.94 (compared to Hybritech Tandem-E PSA) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 145 serum samples were used for the accuracy by correlation study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set. The accuracy by correlation was performed against a legally marketed predicate device (Hybritech Tandem-E PSA), implying its results served as a comparative reference.
4. Adjudication Method for Test Set
- Not applicable, as the evaluation was based on quantitative measurements against a comparative device, not on subjective expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device is a quantitative immunoassay, not an imaging or diagnostic interpretation tool involving human readers.
6. Standalone Performance Study
- Yes, standalone performance was evaluated through precision, recovery, and correlation studies, demonstrating the algorithm's (immunoassay's) performance characteristics independently. The correlation study compared the OPUS PSA's quantitative results directly against those of the predicate device.
7. Type of Ground Truth Used
- For the accuracy by correlation study, the "ground truth" was established by the results obtained from a legally marketed device, the Hybritech Tandem-E PSA. This effectively uses a comparative reference method as the standard for evaluating the new device's performance. For precision and recovery, the ground truth was inherent to the control materials and spiked samples used.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or its size. As this is a 510(k) for an immunoassay, the development process would likely involve calibration and validation using control materials and patient samples, but the specific term "training set" in the context of machine learning is not used.
9. How the Ground Truth for the Training Set Was Established
- Given the nature of an immunoassay, the "ground truth" for what might be considered calibration or development would typically involve:
- Known concentrations: For calibrators, the PSA concentrations are precisely prepared and known.
- Reference materials: Control materials would have established target ranges.
- Clinical samples with expert-verified PSA levels: Patient samples used during development would likely have their PSA values determined by a reference method or established clinical assays.
The document does not provide specifics on how these "ground truths" were established during the development phase.
§ 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.