A “Tumor Associated Antigen Immunological Test System IVD” is an in-vitro diagnostic device that utilizes immunological techniques to measure the presence of tumor-associated antigens (TAAs) in a patient’s bodily fluids like serum, plasma, or urine, serving as an aid in monitoring cancer progression and treatment response by detecting elevated levels of these specific proteins associated with cancerous cells; essentially, it’s a blood test that helps identify potential cancer markers by detecting specific antigens present in the blood that are often elevated in individuals with cancer.

Intended use of Tumor Associated Antigen Immunological Test

A Tumor Associated Antigen Immunological Test System is a device that consists of reagents used to measure qualitatively or quantitatively, 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.

Intended Use:

This is an Automated Immunofluorescent Assay that employs Time-Resolved Amplified Cryptate Emission (TRACE) technology for the quantitative measurement of Chromogranin A levels in human serum. It is intended to be utilized alongside other clinical methods to assist in monitoring disease progression throughout the course of the illness and treatment in patients diagnosed with gastroentero-pancreatic neuroendocrine tumours (GEP-NETs, grades 1 and 2).

Device Description:

The Chromogranin A Test System is an in vitro diagnostic immunoassay intended for the qualitative and/or quantitative measurement of Chromogranin A in human serum or plasma as an aid in monitoring patients with neuroendocrine tumors. The device operates through a specific antigen–antibody immunochemical reaction, in which Chromogranin A present in the specimen binds to antibodies in the test reagents, producing a measurable signal proportional to the antigen concentration.

Thymidine Kinase Activity

Intended Use:

It is an in vitro diagnostic device designed to semi-quantitatively measure thymidine kinase activity (TKa) in human serum. This assay is intended to assist in monitoring disease progression in postmenopausal women with previously diagnosed, hormone receptor-positive, metastatic breast cancer. A TKa value of less than 250 DuA is associated with a reduced likelihood of disease progression within 30 or 60 days after testing. The results should be interpreted in conjunction with other clinical methods for monitoring breast cancer.

Device Description:

The Thymidine Kinase Activity Test System is an in vitro diagnostic device intended to measure thymidine kinase activity in human serum or plasma as an aid in monitoring tumor cell proliferation and disease activity. The device functions by detecting thymidine kinase–related enzymatic or immunochemical activity in the specimen, generating a measurable signal proportional to enzyme activity.

System, Test, Thyroglobulin

Intended Use:

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

Device Description:

The Thyroglobulin Test System is an in vitro diagnostic immunoassay intended for the qualitative and/or quantitative determination of thyroglobulin in human serum or plasma to aid in monitoring patients with differentiated thyroid cancer. The test is based on an immunochemical antigen–antibody reaction between thyroglobulin in the specimen and specific antibodies, followed by signal detection.

System, Test, Carbohydrate Antigen (Ca19-9), for Monitoring and Management of Pancreatic Cancer

Intended Use:

It is a Chemiluminescent Enzyme Immunoassay (CLEIA) used to quantitatively measure antigens in human serum and plasma, aiding in the management of exocrine pancreatic cancer patients.

Device description:

The CA 19-9 Test System is an in vitro diagnostic immunoassay intended for the measurement of carbohydrate antigen 19-9 in human serum or plasma as an aid in monitoring and management of pancreatic cancer. The device operates by immunochemical binding of CA 19-9 antigens to specific antibodies, producing a detectable signal proportional to antigen concentration.

System, Test, Carcinoembryonic Antigen

Intended Use:

The CEA assay employs a paramagnetic particle chemiluminescent immunoassay to quantitatively determine CEA levels in human serum, utilizing Access Immunoassay Systems. Measuring CEA with these systems is instrumental in the management of cancer patients experiencing fluctuations in CEA concentrations.

The quantitative measurement of carcinoembryonic antigen (CEA) levels in human serum and plasma (using EDTA or lithium heparin) is important for managing cancer patients with varying CEA concentrations.

Device Description:

The Carcinoembryonic Antigen Test System is an in vitro diagnostic immunoassay intended for the quantitative measurement of CEA in human serum or plasma as an aid in monitoring patients with certain malignancies. The device uses specific antigen–antibody interactions to detect CEA, with signal generation enabling quantitative determination.

System, Test, Immunological, Antigen, Tumor

Intended Use:

Systems Analyzers quantitatively assess CA15-3 antigen levels in human serum and plasma, aiding in the detection of recurrences in treated stage II and III breast cancer patients and monitoring disease progression in metastatic cases. The Chemiluminescent Enzyme Immunoassay (CLEIA) and the CA assay are used for this evaluation. The CA 15-3 assay is essential for tracking disease progression and treatment response in metastatic breast cancer, as well as for detecting recurrences in previously treated patients. The electrochemiluminescence immunoassay (ECLIA) is also utilized on immunoassay analyzers.

Device description:

The Immunological Tumor Antigen Test System is an in vitro diagnostic immunoassay intended for the qualitative and/or quantitative detection of tumor-associated antigens in human specimens as an aid in monitoring cancer patients. The test functions through immunochemical binding between tumor-associated antigens and corresponding antibodies, resulting in a measurable signal.

System, Test, Tumor Marker, Monitoring, Bladder

Intended Use:

Bladder Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the Real-Time PCR system. Bladder  Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with Non-Muscle Invasive Bladder Cancer.

Device Description:

The Bladder Tumor Marker Test System is an in vitro diagnostic immunoassay intended to detect tumor-associated markers in urine or other appropriate specimens as an aid in monitoring bladder cancer. The device operates using antigen–antibody reactions specific to bladder tumor markers, producing a detectable signal indicative of marker presence or level.

Prostate-Specific Antigen (PSA) for the Management of Prostate Cancers

Intended Use:

This device is intended solely for in vitro diagnostic purposes, specifically for the quantitative assessment of total Prostate Specific Antigen (PSA) in human serum, Li-heparinized plasma, and K3-EDTA plasma. It is recommended for the serial monitoring of total PSA levels to assist in the management of patients diagnosed with prostate cancer.

Device Description:

The PSA Test System is an in vitro diagnostic immunoassay intended for the quantitative determination of prostate-specific antigen in human serum or plasma to aid in the management of prostate cancer. The test measures PSA through immunochemical binding to specific antibodies, followed by signal detection proportional to PSA concentration.

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Intended Use:

The System is used for quantitative measurement of OC 125 antigen concentration in human serum and plasma (EDTA or heparin). This assay aids in monitoring response to therapy for patients with epithelial ovarian cancer

Device description:

The CA-125 Test System is an in vitro diagnostic immunoassay intended for the measurement of epithelial ovarian tumor-associated antigen CA-125 in human serum or plasma as an aid in monitoring ovarian cancer. The device functions via antigen–antibody binding and subsequent signal generation for quantitative analysis.

Kit, Test, Alpha-Fetoprotein for Testicular Cancer

Intended Use:

The Integrated system is used for quantitatively measuring alpha-fetoprotein (AFP) concentrations in human serum to aid in managing non-seminomatous testicular cancer patients.

Device Description:

The Alpha-Fetoprotein Test Kit is an in vitro diagnostic immunoassay intended for the qualitative and/or quantitative measurement of AFP in human serum or plasma as an aid in monitoring and management of testicular cancer. The test operates through immunochemical binding of AFP to specific antibodies, producing a measurable signal proportional to AFP concentration.

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Prozone effect study

CLINICAL TESTING:

No Guidance available for 510k submission