(155 days)
The Bayer ADVIA® IMS cPSA assay is an in vitro diagnostic device intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum. This assay is indicated for the measurement of serum complexed PSA as an aid in management (monitoring) of prostate cancer patients. Complexed PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.
Prostate Specific Antigen (PSA) is a secretory product of the epithelial cells of human prostatic tissue, whether normal, benign, or malignant. The tissue specificity of PSA makes it a sensitive and specific tumor marker as an aid in management (monitoring) prostate cancer patients and disease progression following surgery or other therapies. PSA in serum exists in several forms including free, uncomplexed PSA and PSA complexed to several protease inhibitors including a-2-macroglobulin, a-1antichymotrypsin (ACT), and a-1-antitrypsin. It should be noted that there are no existing commercial methods that can recognize PSA bound to α-2-macroglobulin. However, it has been demonstrated that the proportion of PSA complexed with ACT increases as a function of the total PSA concentration, and that the majority of immunoreactive PSA in cancer patients is in complex with ACT. The Bayer cPSA Assay uses a monoclonal antibody for capture which recognizes both free and complexed PSA, but which, when bound to free PSA, precludes the binding of other antibodies specific for the free form of PSA. The inclusion of a second, unlabelled monoclonal antibody which is specific for free PSA prevents the binding of free PSA in the cPSA assay and allows measurement of only PSA which is complexed with ACT. cPSA can be used as a single test alternative to free and total PSA in management of patients with CaP.
Here's a summary of the acceptance criteria and study details for the Bayer ADVIA® IMS cPSA assay, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (ADVIA IMS cPSA Assay) |
|---|---|
| Imprecision (Total %CV) | |
| Low cPSA Level (~3.5 ng/mL) | 3.0% |
| Mid cPSA Level (~15.5 ng/mL) | 3.4% |
| High cPSA Level (~77.2 ng/mL) | 3.8% |
| Correlation with Predicate Device (Immuno 1) | |
| Regression Equation (Y = ADVIA IMS, X = Immuno 1) | $0.988 * X - 0.191$ (N=98) |
| $1.004 * X - 0.336$ (N=45) | |
| Syx (ng/mL) | 0.706 (N=98) |
| 0.566 (N=45) | |
| R | 0.999 (both N=98 and N=45 sets) |
| Sample Range (ng/mL) | 0.14-86.28 (N=98) |
| 0.03-69.69 (N=45) | |
| Interfering Substances (Observed Recovery Bias) | "no clinical significance" (specific % change provided for various substances, all |
§ 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.