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510(k) K051458

WIESLAB CAP PR-3 ANCA by Eurodiagnostica — Product Code MOB

K051458 is an FDA 510(k) premarket notification submitted by Eurodiagnostica for the device "WIESLAB CAP PR-3 ANCA". The FDA issued a decision of Substantially Equivalent on November 22, 2005. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Eurodiagnostica has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2005
Date Received
June 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Eurodiagnostica

  • K052133 — IMMUNOSCAN RA ANTI-CCP TEST SYSTEM (December 12, 2005)
  • K051455 — WIESLAB CAP MPO-ANCA (November 23, 2005)

Other clearances for product code MOB

  • K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM (August 21, 2026)
  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (March 23, 2018)
  • K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (March 13, 2018)
  • K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (February 3, 2017)
  • K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB (October 27, 2014)
  • K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (July 31, 2012)
  • K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (November 3, 2010)
  • K092601 — IMMULISA ANCA SCREEN ELISA (October 7, 2010)

FDA data resources