Human Chorionic Gonadotropin (HCG) Test

A Calcitonin Test System is a diagnostic tool used to measure calcitonin; a hormone that helps regulate calcium levels in the blood. It is primarily used to diagnose and monitor conditions like medullary thyroid cancer (MTC), hypercalcemia, and other thyroid-related disorders.

A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Intended use: It is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

Device Description: Chemiluminescent immunoassay (CLIA) is used for the quantitative determination of total β-hCG (human chorionic gonadotropin) levels in human serum and plasma. These assays are commonly used in clinical laboratories for detecting and monitoring pregnancy. This method relies on a chemical reaction that produces light. The amount of light emitted correlates with the concentration of β-hCG in the sample These are used to capture the specific analyte (in this case, β-hCG) in the blood sample. The particles bind to antibodies that are specific for β-hCG, forming an immune complex. The immunoassay uses antibodies that specifically bind to the β-hCG hormone. Once the immune complex is formed (with the paramagnetic particle and antibody binding to β-hCG), it is subjected to a reaction that emits light, which is then measured. The amount of light produced is directly proportional to the concentration of β-hCG in the sample.

Intended use: HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Description: The HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

Intended use: HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy

Device Description: The HCG Test (Midstream, Cassette, and Strip) is a diagnostic device designed for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. The principle behind these tests is based on immunochromatographic technology, where the test strip, cassette, or midstream device contains antibodies that specifically bind to the HCG hormone. When urine containing HCG is applied to the device, a reaction occurs that causes a color change, indicating the presence of the hormone. These tests are user-friendly, non-invasive, and provide results within a few minutes, with a visual line appearing to confirm a positive result. The three formats (Midstream, Cassette, and Strip) work similarly, but differ in their method of urine application, either by directly placing the device in the urine stream, using a dropper to apply the sample, or dipping the strip into the collected urine. These devices provide a fast, convenient, and reliable way to detect early pregnancy at home.

• precision/Reproducibility
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Interference
• Analytical Sensitivity
• Hook effect test

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking