(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 |
§ 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.