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510(k) Data Aggregation
(83 days)
The Bayer Immuno 1™ cPSA Assay is an in vitro diagnostic assay intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum on the Bayer Immuno I™ System. Complexed prostate specific antigen (cPSA) values obtained should be used as an aid in the management (monitoring) of prostate cancer patients.
The Bayer Immuno ITM cPSA Assay utilizes the same immunoassay technology and the same R1 and R2 reagents as in the Bayer Immuno ITM PSA Assay except for the addition of a third, unlabeled, monoclonal antibody to the R2 reagent. Reagent 1 (or R1) contains monoclonal PSA antibody conjugated to fluorescein while Reagent 2 (or R2) contains polyclonal PSA antibody conjugated to alkaline phosphatase and a third unlabeled antibody specific for free PSA. The R1 and R2 conjugates are reacted with patient sample, calibrator, or control and are incubated at 37℃ on the system. Free PSA in the serum is bound by the unlabeled free PSA antibody while the remaining complexed PSA is bound by the PSA antibody conjugated to alkaline phosphatase. Immuno 1 Magnetic Particles coated with an anti-fluorescein antibody are then added and a second incubation occurs during which the antibody enzyme conjugate complex is bound. Washing of the particles is followed by addition of substrate (PNPP) reagent. The rate of conversion of substrate to a compound with absorbance at 405 and 450 nm is measured and the measured rate is proportional to the concentration of cPSA antigen in the sample. A cubic-through-zero curve fitting algorithm is used to generate standard curves.
The assay has a range of 0.02 to 100 ng/mL. The Bayer Setpoint™ Complexed PSA (cPSA) Calibrators consist of a set of six calibrator levels at 0, 2, 10, 25, 50, and 100 ng/mL. The Bayer Setpoint™ Complexed PSA (cPSA) Controls consist of a set of 3 control levels at approximately 3.5, 15, and 75 ng/mL.
Bayer Immuno 1™ Complexed PSA (cPSA) Assay
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document defines acceptance criteria for various analytical performance characteristics. Clinical effectiveness is established by demonstrating equivalence to a predicate device (Bayer Immuno 1™ PSA Assay) in monitoring prostate cancer patients.
| Performance Metric | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Specificity: Interference | +/- 10% deviation in cPSA recovery | None of the tested endogenous or exogenous interferents (triglycerides, immunoglobulin, hemoglobin, heparin, bilirubin, albumin, chemotherapeutic drugs, OTC drugs, vitamins) demonstrated significant interfering effects (outside +/- 10% deviation). |
| Cross-Reactivity | Maximum effect seen with cross-reactant ≤ 1% (not explicitly stated as criteria, but implied as significant) | Maximum effect seen with kallikrein, trypsin, and chymotrypsin was not significant (≤ 1%). |
| Heterophilic Antibodies | Lack of significant heterophilic interference | Lack of significant heterophilic interference observed across 206 patient samples with HAMA, RF titers, or autoimmune diseases, demonstrating effective reagent formulation. |
| Linearity (Dilution) | Recoveries between 95% and 105% of expected values (implied) | Recoveries of intermediate dilutions were all between 95% and 103% of the expected values, demonstrating linearity over the entire calibration range. |
| Hook Effect (Antigen Excess) | No hook effect within a relevant physiological range (implied) | No hook effect observed at cPSA values ≤ 12,500 ng/mL, covering the range of potentially extremely high concentrations. |
| Parallelism (Sample Dilution) | Linear regression showing no deviation from linearity; recovery of diluted values between 90-110% (implied) | Linear regression analysis showed no deviation from linearity for diluted patient samples. Recovery of cPSA assay values ranged from 97.0% to 107.6%, demonstrating Level 1 calibrator as an acceptable diluent. |
| Reproducibility (Total %CV) | "Well within acceptable limits for an assay of this type" (implied as <5% or similar) | Pooled total coefficients of variation (%CV) across three clinical sites and three reagent lots: - Serum Pool (0.67 ng/mL): 2.3% - Control Level 1 (3.35 ng/mL): 2.3% - Control Level 2 (14.88 ng/mL): 2.0% - Control Level 3 (74.34 ng/mL): 2.4% All "well within acceptable limits." |
| Sensitivity (Detection Limit - MDC) | Acceptable for an "ultrasensitive complexed PSA assay" (implied <0.05-0.1 ng/mL) | 0.016 ng/mL observed, qualifying it as an ultrasensitive method. |
| Clinical Performance | ||
| Serial Monitoring (Agreement with Clinical Status) | High agreement between cPSA concentrations and patient clinical status | Agreement between serum complexed PSA concentrations and patients' clinical status for 150 out of 155 (97%) longitudinally monitored prostate cancer patients. |
| Serial Monitoring (Trending Agreement with Predicate) | Identical patterns of increases/decreases compared to predicate (Immuno 1 PSA Assay) | Immuno 1 cPSA Assay and Immuno 1 PSA Assay showed identical patterns of increases and decreases for serially monitored patients, demonstrating equivalent management value. |
| Distribution of cPSA Concentrations | Equivalent to predicate and literature values for same population groups | Distribution of complexed PSA concentrations determined by Immuno 1 cPSA Assay is equivalent to the distribution of total PSA concentrations by the Immuno 1 PSA Assay and similar to literature values. |
2. Sample Size Used for the Test Set and Data Provenance
- Analytical Studies (Interference, Cross-Reactivity, Heterophilic Antibodies, Linearity, Hook Effect, Parallelism): The exact sample sizes for each specific analytical test (e.g., number of spiked samples, number of patient samples for linearity) are not always individually specified but involve various serum samples, pools, and controls. For heterophilic antibodies, 206 patient samples were used.
- Reproducibility: 358-360 replicates across three clinical sites, three reagent lots, and two calibrator lots for each of the four control/serum pool levels.
- Sensitivity (MDC): 717 replicates of the zero calibrator.
- Clinical Efficacy (Serial Monitoring): 155 patients with malignant prostate disease.
- Data Provenance: Retrospective. "All patients were studied retrospectively. Assay values were determined for surplus serum samples which had been collected and stored (-70° C) in specimen banks prior to the study."
- Country of Origin: Three US clinical trial sites.
- Clinical Efficacy (Distribution of cPSA Concentrations): No specific number is given for the "healthy females, healthy males, patients with active prostate cancer, male patients with benign urogenital diseases, male patients with various non-urogenital non-malignant diseases, and male patients with various malignant diseases of non-prostate origin."
- Data Provenance: Retrospective, from "specimen banks," likely from the same three US clinical trial sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document states: "Patient case histories were well conducted by qualified experts." However, it does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth (clinical status for serial monitoring). It implies that the clinical status (progressive, recurrent, successful therapy) was determined by the treating physicians at the "three US clinical trial sites."
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "ground truth" for the clinical study appears to be the patients' recorded clinical status, as determined by their treating physicians. The comparison is made between the trends in cPSA values and the "patients' clinical status," which is based on individual patient medical histories.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed as this is an in vitro diagnostic (IVD) assay quantifying a biomarker, not an imaging device or a diagnostic tool requiring human interpretation comparison. The clinical study compared the assay's performance to the patient's clinical outcome and to a predicate device (Immuno 1 PSA Assay), not to human readers' interpretations.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies reported are for the standalone performance of the Immuno 1 cPSA Assay. The device measures complexed PSA levels quantitatively. The "human-in-the-loop" aspect would be a physician interpreting these results for patient management, which is the intended use, but the performance data presented are purely analytical and then correlated with clinical outcomes.
7. The Type of Ground Truth Used
For the clinical effectiveness study, the primary ground truth used was outcomes data / clinical status. This involved:
- "Patients' clinical status" (progressive, recurrent disease, successful therapy following surgery/radiation/chemotherapy/hormonal therapy).
- "Medical history" collected for each patient.
- Comparison to the performance of a predicate device (Bayer Immuno 1™ PSA Assay), which itself had FDA Pre-Market Approval (PMA) for managing prostate cancer patients.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size in the context of machine learning or algorithm development. This assay is a biochemical immunoassay, not a machine learning model that undergoes explicit training on a dataset. The development and optimization of the assay's reagents and calibration curve would have involved extensive R&D and internal testing, but this is distinct from "training a model" with a labeled dataset as might be done for AI.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, since this is a biochemical immunoassay, there isn't a "training set" in the sense of a dataset used to train an AI model. The "ground truth" for establishing its analytical performance characteristics (like linearity, calibration, specificity) would be based on:
- Known concentrations of purified cPSA or spiked samples.
- Reference methods or established physiochemical properties.
- Comparative analysis against the predicate Immuno 1 PSA Assay for clinical equivalence.
For example, the calibrators are defined at specific known concentrations (0, 2, 10, 25, 50, and 100 ng/mL) of purified PSA-ACT. This purified antigen and its known concentrations would serve as the "ground truth" for calibrator development and assay linearity studies.
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