An Immunoglobulins A, G, M, D, and E Immunological Test System refers to a medical laboratory test that measures the levels of five different types of antibodies in the blood, known as immunoglobulins (IgA, IgG, IgM, IgD, and IgE), providing information about the overall health and function of a person’s immune system; essentially, it checks how much of each specific antibody is present in the blood, which can help diagnose conditions related to immune deficiencies or overactive immune responses like allergies.

Intended Use of Immunoglobulins A, G, M, D, and E Immunological Test System

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins’ aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Intended Use:

It is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis

Device Description:

Immunoelectrophoresis is a laboratory technique that combines electrophoresis and immunodiffusion to identify and analyze proteins in bodily fluids, particularly immunoglobulins (antibodies). This method separates proteins based on size and charge, then uses specific antibodies to form visible bands, enabling the detection of particular proteins. The primary immunoglobulins analyzed are IgG, which provides long-term immunity against infections; IgA, crucial for mucosal immunity in areas like the respiratory and gastrointestinal tracts; and IgM, the first antibody produced during an initial immune response. Immunoelectrophoresis helps diagnose immune disorders, infections, and other conditions by assessing these immunoglobulins’ levels and patterns in the serum.

Intended Use:

In-vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometric System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agent

Device Description:

The Nephelometric method is a technique used to measure the concentration of substances, like immunoglobulins, by detecting light scattered by particles in a solution. In the case of immunoglobulins (e.g., IgA, IgG, IgM), specific antibodies are added to the sample to form immune complexes, which scatter light. The amount of scattered light is proportional to the immunoglobulin concentration, which is then quantified by comparing it to a standard curve. This method is commonly used in clinical labs for its accuracy and sensitivity in diagnosing immune-related conditions.

Intended Use:

It is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist office

Device Description:

Test System is an automated lateral flow immunoassay designed to measure total IgE levels in human capillary whole blood. It consists of several components: Total IgE Cartridge, External Controls (low and high), the instrument with a detachable tablet screen, the Sample Collection Kit (SCK), and the Developing Solution. The test works by loading a fingerstick blood sample into the instrument, which automatically dispenses the sample onto the cartridge and adds the developing solution. The sample flows along a membrane where immobilized anti-human IgE antibodies capture IgE from the sample, producing a fluorescent signal proportional to the IgE level. This signal is measured, and results are displayed. The system is intended for use in point-of-care settings and provides a fast, automated method for IgE testing.

• Stability Studies
• Precision/Reproducibility
• Linearity/assay reportable range
• Detection limit
• Analytical Specificity / Cross-Reactivity
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Interference
• Precision /reproducibility
• Hook Effect
• Specimen Stability

Clinical Testing

No Guidance available  for 510k submission