CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Device Facts
| Record ID | K022329 |
|---|---|
| Device Name | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
| Applicant | Bayer Diagnostics Corp. |
| Product Code | LTK · Immunology |
| Decision Date | Nov 27, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
Indications for Use
This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer using ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™. CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostics procedures. The CA 125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone firstline therapy and would be considered diagnostic second-look procedures. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system. An assay value of greater than 35 UlmL is predictive of residual disease, provided that alrernate causes of elevated CA 125 II Assay values can be excluded. It is recommended that the assessment and treatment of patients with ovarian cancer and the use of this CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecologic cancers.
Device Story
In vitro immunoassay for quantitative measurement of OC 125 reactive determinants in serum; used on Bayer ADVIA IMS system. Operates via immunoassay principle to detect high molecular weight glycoprotein associated with ovarian cancer. Used in clinical laboratory settings by trained technicians; results interpreted by physicians specializing in gynecologic oncology. Output provides numerical CA 125 II concentration (U/mL); values >35 U/mL suggest residual disease. Assists clinicians in monitoring disease progression or response to therapy (doubling values indicate progression; 50% decrease indicates response). Benefits patients by providing objective data for longitudinal management and post-therapy assessment.
Clinical Evidence
Bench testing only. Performance evaluated via correlation with predicate (N=45, R=0.994), linearity, parallelism, and interference studies (hemoglobin, lipids, bilirubin, drugs, vitamins). Sensitivity 94.7%, specificity 22.2%, PPV 72.0%, NPV 66.7%, concordance 71.4%. Analytical range 0.5-550 U/mL. No clinical prospective trials presented; longitudinal monitoring data provided as comparative examples.
Technological Characteristics
In vitro immunoassay; quantitative measurement of OC 125 reactive determinants. System: Bayer ADVIA IMS. Analytical range: 0.5-550 U/mL. Minimum detectable concentration: 0.5 U/mL. Connectivity: Integrated modular system. No specific materials or software algorithm architecture details provided.
Indications for Use
Indicated for women with primary epithelial invasive ovarian cancer to aid in disease management (monitoring) and as a one-time test to aid in detecting residual carcinoma post-first-line therapy for patients considered for second-look procedures. Not for screening or primary diagnosis.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Immuno 1 CA125 II Assay (T01-3560-51)
