An antinuclear antibody (ANA) test is a blood test that looks for antibodies that attack the body’s own cells. It’s used to help diagnose autoimmune disorders

Intended Use of Antinuclear Antibody Immunological Test System

An antiparietal antibody immunological test system is a device that consists of reagents used to measure immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces anti-bodies against its own tissues).

Intended Use:

It is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate.

Device Description:

Antinuclear antibodies (ANA) are crucial in diagnosing systemic autoimmune connective tissue disorders, such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, and autoimmune hepatitis. ANA testing using indirect immunofluorescence assay (IFA) with HEp-2 cells is considered the gold standard due to its ability to detect various ANA patterns.

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Intended Use:

An enzyme linked immunoassay (ELISA) for the qualitative or semi‐quantitative detection of anticentromereIgG antibodies in human serum as an aid in diagnosis of limited cutaneous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.

Device Description:

The Antinuclear Antibody (Enzyme-Labeled) Device is a diagnostic tool used to detect the presence of antinuclear antibodies (ANA) in a patient’s blood. It utilizes an enzyme-linked immunosorbent assay (ELISA) to identify these antibodies, which are indicative of autoimmune disorders. The device works by attaching specific nuclear antigens to the surface, and if ANA is present, it binds to these antigens. The binding is then detected by an enzyme-labeled secondary antibody, which triggers a color change. This allows healthcare providers to assess the likelihood of autoimmune diseases such as lupus, rheumatoid arthritis, and others.

Antinuclear Antibody, Antigen, Control

Intended Use:

 It is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro52 in human serum as an aid in the diagnosis of Sjogren’s syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM) in conjunction with other laboratories and clinical findings.

Description Device:

The device is an in vitro diagnostic test kit used to semi-quantitatively measure IgG antibodies against the Ro52 antigen in human serum. It is designed to aid in the diagnosis of autoimmune diseases such as Sjogren’s Syndrome, Systemic Lupus Erythematosus, Systemic Sclerosis, and Idiopathic Inflammatory Myopathies. The test typically uses immunoassay or ELISA technology to detect Ro52 antibodies, with results that help guide clinical diagnosis when combined with other laboratory findings. The kit includes reagents like control samples and is intended for use by trained laboratory personnel, with performance characteristics such as sensitivity and specificity provided by the manufacturer.

Anti-Sm Antibody, Antigen And Control

Intended use:

It is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratories and clinical findings

Device Description:

The test system is a fully automated fluor immunoassay used to detect autoantibodies against Sm. It includes assay-specific reagents like synthetic SmD3 peptide-coated wells, positive and negative control solutions, and method-specific reagents such as sample diluent and IgG conjugate. These components are ready to use and are essential for conducting the test and ensuring its accuracy.

Extractable Antinuclear Antibody, Antigen And Control

Intended use:

It is a chemiluminescent immunoassay for the semi-quantitative determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (II)

Device Description:

The test system is a chemiluminescent immunoassay designed to detect IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) in human serum. It is intended for semi-quantitative determination of these antibodies, and when used alongside clinical findings and other laboratory tests, it aids in diagnosing idiopathic inflammatory myopathy (IIM). The assay is run on the BIO-FLASH® instrument, which automates sample processing, testing, and result reporting. The test utilizes a reagent cartridge containing HMGCR-coated paramagnetic beads and isoluminol-labeled anti-human IgG antibodies. The presence of the antibody is indicated through a luminescent reaction that generates relative light units (RLU), which are used to calculate the results.

Anti-Ribosomal P Antibodies

Intended use:

It’s intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemiclupus erythematosus (SLE) in conjunction with other laboratories and clinical findings.

Device Description:

The Anti-Ribosomal P Antibodies (MQA) test is used for the semi-quantitative measurement of IgG antibodies directed against ribosomal P proteins in human serum, aiding in the diagnosis of systemic lupus erythematosus (SLE). This test is typically used alongside other laboratory results and clinical findings to assist healthcare providers in identifying SLE, particularly in cases where the diagnosis is uncertain. The presence of these antibodies can be associated with neuropsychiatric lupus and other severe manifestations of the disease, making it a valuable diagnostic tool for confirming SLE in patients.

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Intended use:

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase Iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use

Device Description:

The system tests are fluorescence immunoassays used to detect and measure human antibodies. These tests use solid-phase components, which are polystyrene wells coated with specific antigens. When patient samples are tested, antibodies bind to their respective antigen in the well. After washing away unbound antibodies, enzyme-labeled antibodies are added to form an antibody-conjugate complex. The complex is incubated with a Development Solution, and the fluorescence signal is measured. The intensity of fluorescence correlates with the amount of antibody present in the sample. The test results are compared to a calibrator to evaluate the amount of antibody detected.

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

Clinical Testing

No Guidance available  for 510k submission