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510(k) K250814

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB by Zeus Scientific — Product Code OBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
March 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ss-A 52 Autoantibodies
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Other clearances by Zeus Scientific

  • K250666 — Alegria Flash CTD Screen (October 22, 2025)
  • K250408 — Alegria Flash ENA Screen (September 19, 2025)
  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (August 31, 2023)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (July 26, 2012)

Other clearances for product code OBE

  • K141655 — QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS (March 5, 2015)
  • K063565 — QUANTA LITE SS-A 52 ELISA (April 4, 2007)