Cleared Traditional

Alegria Flash SSA-60 (K250814) - FDA 510(k) Clearance

Also marketed or referenced as:
Alegria Flash SSA-52 Alegria FLash SSB

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250814 · Zeus Scientific · Immunology device
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May 2026
Decision
417d
Days
Class 2
Risk

K250814 is an FDA 510(k) clearance for the Alegria Flash SSA-60. Classified as Anti-ss-a 52 Autoantibodies (product code OBE), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on May 8, 2026 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Zeus Scientific devices

Submission Details

510(k) Number K250814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2025
Decision Date May 08, 2026
Days to Decision 417 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 104d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBE Anti-ss-a 52 Autoantibodies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.