Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB— 510(k) K250814
Substantially EquivalentZeus Scientific
FDA 510(k) clearance K250814 for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB, Substantially Equivalent on 2026-05-08. Applicant: Zeus Scientific. Device class: 2.
Summary
Zeus Scientific's record covers three Alegria Flash items: SSA-60, SSA-52 and SSB. The product code is OBE, anti-SS-A 52 autoantibodies.
Class II, 21 CFR 866.5100. Immunology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Zeus Scientific filed from Branchburg, New Jersey. The decision came 417 calendar days after receipt (March 17, 2025 to May 8, 2026).
Clearance details
- Applicant
- Zeus Scientific
- Product code
- Product code OBE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code OBE
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view all- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
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- K250408 — Alegria Flash ENA Screen
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
Data sourced from openFDA. This site is unofficial and independent of the FDA.