← Back to catalogue

Wieslab Cap PR-3 ANCA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051458

by Eurodiagnostica

Identifiers

510(k) Number
K051458 FDA 510(k)
FDA Product Code
MOB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5660 FDA 510(k)
Regulation Number
866.5660 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wieslab Cap PR-3 ANCA is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. It is a test system for antineutrophil cytoplasmic antibodies (ANCA) used in immunology.

The device is supplied as a kit for in vitro diagnostic use. It received FDA 510(k) clearance (K051458) as a substantially equivalent device under regulation number 866.5660, classified as a Class II medical device with product code MOB. It is intended for use in clinical laboratory settings.

Frequently asked questions

What is the Wieslab Cap PR-3 ANCA test used for?

The Wieslab Cap PR-3 ANCA test is an enzyme-linked immunosorbent assay (ELISA) designed for the detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. It is used as part of the diagnostic workup for antineutrophil cytoplasmic antibodies (ANCA), which are associated with certain autoimmune vasculitides, and is intended for use in clinical laboratory settings.

How is the Wieslab Cap PR-3 ANCA supplied and is it reusable?

The Wieslab Cap PR-3 ANCA is supplied as a kit for in vitro diagnostic use. It is a single-use test system, meaning all components are intended for one-time use only and should not be reused. Reuse could compromise test accuracy and increase the risk of contamination or invalid results.

What regulatory clearance does the Wieslab Cap PR-3 ANCA have?

The Wieslab Cap PR-3 ANCA received FDA 510(k) clearance under submission number K051458, which was granted on November 22, 2005. It was found to be substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under regulation 866.5660 with product code MOB.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Wieslab® Capture PR3-ANCA ELISA and Capture MPO-ANCA ELISA, WIESLAB CAP PR-3 ANCA (K051458) — FDA 510 (k) | Innolitics, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Eurodiagnostica

Sources (1)

  • FDA 510(k) K051458 24 fields · synced Sep 22, 2026