(339 days)
The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
The DSL 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the microtiter plate wells, the other antibody is conjugated the the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
The provided text describes the DSL 10-9700 PSA ELISA Kit and its substantial equivalence study. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for the new device itself. Instead, it demonstrates substantial equivalence to a predicate device. The performance criterion implicitly accepted is a strong linear correlation and agreement with the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (DSL 10-9700 PSA ELISA) |
|---|---|---|
| Correlation with Predicate Device (DPC IMMULITE PSA) | Strong linear correlation | Linear regression: Y = 1.11[DPC IMMULITE] + 0.77 |
| High correlation coefficient | Correlation coefficient (r) = 0.96 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 193 human serum samples.
- Data Provenance: The document states "human serum samples (n = 193) were collected." It does not specify the country of origin of the data. The samples were chosen "based on expected PSA levels so that samples with low, intermediate and high levels would be evaluated."
- Retrospective or Prospective: Not explicitly stated, but the description "samples were collected and assayed using both methods" suggests a prospective collection of samples for the purpose of the comparison study, or at least a concurrent analysis of an already collected sample bank. It does not definitively state if these were newly drawn specifically for this study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study establishes equivalence to a predicate device, not against an independent 'ground truth' established by experts interpreting clinical outcomes or pathology. The "ground truth" in this context is the results obtained from the predicate DPC IMMULITE PSA assay.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described, as the comparison was between two assays, not expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is an in vitro diagnostic device for measuring a biomarker, not an imaging or diagnostic device requiring human interpretation of results in the traditional sense of an MRMC study. The comparison is between two laboratory assays.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The DSL 10-9700 PSA ELISA kit is a standalone assay (a laboratory test) that provides a quantitative measurement. Its performance is evaluated intrinsically through its ability to quantify PSA and extrinsically by comparing its results to a legally marketed predicate device. There is no "human-in-the-loop" decision-making component for the device itself; humans operate the device and interpret its quantitative output.
7. The Type of Ground Truth Used
The "ground truth" for the comparative effectiveness study was the results obtained from the DPC IMMULITE PSA assay, which is itself a legally marketed and presumably validated assay for Total PSA. The study aimed to show that the new device's measurements align closely with the predicate device's measurements.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. The ELISA kit is a biochemical assay. The 193 samples were used for the equivalence comparison study, which can be considered analogous to a "test set" for validating performance against a standard.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm or AI in this context, this question is not applicable. The device is a laboratory assay.
§ 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.