Euroimmun Anti-Desmoglein 1 ELISA (IgG), Anti-Desmoglein 3 ELISA (IgG)

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)

510(k) Number

K091969 ↗

FDA Product Code

NBO

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Euroimmun Anti-M2-3E Elisa (Igg)

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• Euroimmun Anti Bp 180-4X Elisa (Igg)

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• Euroimmun Anti-Hsv-2 Elisa (Igg) and Anti-Hsv-1 Elisa (Igg) Kit

  Class II

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See all devices from Euroimmun Us Inc. →

• What autoimmune skin conditions can these ELISA tests help identify, and how do they work?

  These assays detect IgG autoantibodies against desmoglein 1 and desmoglein 3 proteins, which are key components of skin cell adhesion. Elevated levels of these antibodies are linked to autoimmune blistering disorders like pemphigus vulgaris (targeting both desmoglein 1 and 3) and pemphigus foliaceus (targeting desmoglein 1). The tests use enzyme-linked immunosorbent assay (ELISA) technology to measure antibody presence in human serum or plasma by binding to antigen-coated microplate wells, enabling laboratory confirmation of suspected autoimmune dermatological conditions.

• Are these kits designed for single-use or repeated testing, and how should they be stored?

  The kits are explicitly supplied as single-use diagnostic reagents, meaning each microplate or component is intended for one analysis cycle only. Storage instructions are not detailed in the provided data, but typical ELISA reagents require refrigeration (2–8°C) and protection from light until use. Always refer to the included package insert for precise storage conditions and expiration details.

• What type of laboratory personnel are qualified to use these assays, and what sample types can they analyze?

  These assays are intended for use by trained laboratory personnel, such as clinical laboratory scientists or technicians with experience in immunology and ELISA techniques. They are designed to analyze human serum or plasma samples, which should be collected and processed according to standard clinical laboratory protocols to ensure accurate antibody detection.

• How are these devices regulated, and what does the FDA’s 510(k) clearance indicate about their safety and performance?

  These assays are regulated under the FDA’s 510(k) clearance pathway (K091969) and classified as Class II medical devices (regulation number 866.5660). The clearance indicates that Euroimmun demonstrated the devices are substantially equivalent to a legally marketed predicate device in terms of safety and performance. This does not imply approval for specific clinical uses but confirms compliance with FDA requirements for in vitro diagnostic assays targeting autoantibodies in immunology.