Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM— 510(k) K261466
Substantially EquivalentZeus Scientific
FDA 510(k) clearance K261466 for Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM, Substantially Equivalent on 2026-08-21. Applicant: Zeus Scientific. Device class: 2.
Summary
Zeus Scientific's submission lists three assays: Alegria Flash MPO, Alegria Flash PR3, and Alegria Flash GBM. The product code is MOB, antineutrophil cytoplasmic antibodies (ANCA) test systems.
Class II, 21 CFR 866.5660. Immunology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Zeus Scientific filed from Branchburg, New Jersey. The decision came 109 calendar days after receipt (May 4 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Zeus Scientific
- Product code
- Product code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code MOB
view all- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
More clearances from Zeus Scientific
view all- K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
- K250666 — Alegria Flash CTD Screen
- K250408 — Alegria Flash ENA Screen
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.