Wielisa PR-3 ANCA Test System

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

510(k) Number

K974167 ↗

FDA Product Code

MOB

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Wielisa Mpo Anca Test System

  Class II

  FDA 510(k) K974166 Active Cleared 17 Feb 1998

• Wielisa Anca Screening Kit Test System

  Class II

  FDA 510(k) K981748 Active Cleared 22 Jul 1998

• Wielisa Anti-Gbm Test System

  Class II

  FDA 510(k) K974169 Active Cleared 17 Feb 1998

• Wielisa Anti-Gbm, Anca Screening Kit Test System

  Class II

  FDA 510(k) K981750 Active Cleared 22 Jul 1998

• What is the Wielisa PR-3 ANCA Test System used for?

  The Wielisa PR-3 ANCA Test System is an enzyme-linked immunosorbent assay (ELISA) designed specifically for the detection and semi-quantitative measurement of antibodies to Proteinase-3 (PR-3) in human serum. These antibodies are associated with certain autoimmune conditions, such as Wegener’s granulomatosis, helping clinicians identify patients who may require further diagnostic evaluation or monitoring. The test does not diagnose or treat the condition but provides critical laboratory data to support clinical decision-making.

• How is the Wielisa PR-3 ANCA Test System supplied and intended for use?

  The Wielisa PR-3 ANCA Test System is intended for single-use in clinical laboratory settings. It requires human serum samples for testing and is designed to be used following standard ELISA-based assay protocols. The system is not meant for point-of-care or home use but is intended exclusively for professional laboratory environments where trained personnel can handle and interpret the results accurately.

• Is the Wielisa PR-3 ANCA Test System sterile and how should it be stored?

  The Wielisa PR-3 ANCA Test System is supplied in a format consistent with ELISA-based assays, which typically require sterile handling to prevent contamination. While the exact sterility claims are not detailed in the provided data, standard laboratory practices for ELISA systems—such as refrigeration (usually between 2°C and 8°C) and protection from light—should be followed. Always refer to the included instructions for storage and handling to ensure optimal performance and validity of results.

• What regulatory pathway was followed for the Wielisa PR-3 ANCA Test System?

  The Wielisa PR-3 ANCA Test System received FDA 510(k) clearance through the Traditional pathway, confirming its compliance with U.S. regulatory standards. This pathway involves demonstrating that the device is substantially equivalent to a legally marketed predicate device. The system is classified as a Class 2 medical device under FDA regulations, specifically under product code MOB, which pertains to immunology diagnostic tests.

• Are there different models or sizes available for the Wielisa PR-3 ANCA Test System?

  The provided data does not specify multiple models or sizes for the Wielisa PR-3 ANCA Test System, indicating it is likely offered as a single standardized test kit. However, the system may include components such as test strips, reagents, and controls tailored for semi-quantitative analysis. For precise details on kit contents or variations, consult the manufacturer’s instructions or technical documentation accompanying the product.