510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250814Substantially Equivalent

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Zeus Scientific LLC, Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K250814 is the FDA 510(k) clearance record for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB, a class II device, cleared for Zeus Scientific on under FDA product code OBE (Anti-Ss-A 52 Autoantibodies). FDA's definition for product code OBE reads: "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...". FDA records list 141 510(k) clearances for Zeus Scientific, from to . As of , FDA records show no recalls naming K250814.

Clearance record

Decision date
Received
(417 days to decision)
Product code
OBE Anti-Ss-A 52 Autoantibodies
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Zeus Scientific 200 Evans Way, Branchburg NJ
510(k) summary
Statement
Third party review
No

Clearances, product code OBE

Trailing 12 months
1 clearance under product code OBE in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OBE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260