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510(k) Data Aggregation

    K Number
    K980376
    Device Name
    THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    1998-04-23

    (83 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 MetricAcceptance Criteria (Implicit/Explicit)Reported Device Performance
    Analytical Performance
    Specificity: Interference+/- 10% deviation in cPSA recoveryNone 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-ReactivityMaximum 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 AntibodiesLack of significant heterophilic interferenceLack 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
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