Immuglo Anti-Neutrophil Cytoplasmic Antibody Anca Test Sytem

FDA-Cleared Indications

• Used to detect anti-neutrophil cytoplasmic antibodies in patient specimens.
• Used as an aid in the diagnosis of autoimmune vasculitis.
• Intended for use by qualified clinical laboratories according to the manufacturer’s instructions.

Clinical Applications

• Laboratory evaluation of patients with clinical findings suggestive of autoimmune vasculitis.
• Testing for ANCA patterns associated with suspected granulomatosis with polyangiitis.
• Supporting the diagnostic workup of suspected microscopic polyangiitis and related ANCA-associated vasculitides.
• Interpreting ANCA results alongside clinical findings and other laboratory or diagnostic tests.

Reported off-label uses

• Research or adjunctive evaluation of other inflammatory or autoimmune disorders when specifically validated by the laboratory.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• This is a laboratory diagnostic assay, not an implantable or therapeutic device.
• Patient specimens must be collected, stored, processed, and tested according to the manufacturer’s instructions and laboratory quality standards.
• Immunofluorescence patterns require trained personnel and appropriate laboratory equipment for interpretation.
• A positive or negative ANCA result does not establish or exclude vasculitis by itself; results should be interpreted with the clinical presentation and other testing.
• MRI compatibility, implant size, and vascular access considerations do not apply because the system is not an implanted or intravascular device.