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# PerkinElmer 510(k) Cleared for Vasculitis Assays
- URL: https://www.fdaweb.com/perkinelmer-510-k-cleared-for-vasculitis-assays/
- Published: 2018-07-25T12:00:00.000Z
- Updated: 2026-09-15T00:21:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141963

FDA has cleared a PerkinElmer 510(k) for its [EuroImmun ANCA IFA and Europlus Granulocyte Mosaic](http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.euroimmun.com%2Fproducts%2Findications%2Fautoantikrper-diagnostik%2Frheumatology%2Fvasculitis%2Faak-gegen-granulocyten-anca.html&esheet=51842944&newsitemid=20180725005686&lan=en-US&anchor=EUROIMMUN+ANCA+IFA+and+EUROPLUS+Granulocyte+Mosaic%E2%84%A2&index=2&md5=e0b28b3209775dbeb8ea19a6b62a4455&ref=fdaweb.com) assays and their use with the EuroPattern microscope. The assays are designed as indirect immunofluorescence tests for the qualitative or semi-quantitative determination of anti-neutrophil cytoplasmic antibodies ANCAof immunoglobulin class IgG in human serum. They are used to aid in the diagnosis of ANCA-associated vasculitis, which affects 42 out of 100,000 people in the U.S., according to the company.