K-number	K243776
Device name	Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
Applicant	Zeus Scientific
Product code	MOB
Device class	Class II
Decision date	May 7, 2025
Decision	Substantially Equivalent
Regulation	866.5660

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This device is an indirect immunofluorescence assay (IFA) that detects anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum. It comes in two versions—ethanol-fixed and formalin-fixed—and can be performed manually by fluorescence microscopy or with automated analysis using dIFine software. Results aid in diagnosing ANCA-associated vasculitis (AAV) when combined with other clinical and laboratory findings.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The clearance letter confirms substantial equivalence to legally marketed predicate devices but does not provide the detailed technical or comparative reasoning used to reach that determination. The enclosure referencing the specific predicate comparison is referenced but not included in the document pages provided.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

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