# K250814: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific
- Decided: May 8, 2026 after 417 days
- Product code: OBE (Anti-Ss-A 52 Autoantibodies)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Alegria Flash SSA-52: The Alegria Flash SSA-52 kit uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgG antibodies to SSA-52 in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SJS), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SS), Polymyositis (PM), and Dermatomyositis (DM) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument Alegria Flash SSA-60: The Alegria Flash SSA-60 kit uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgG antibodies to SSA-60 in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SS) and Systemic Lupus Erythematosus (SLE) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument Alegria Flash SSB: The Alegria Flash SSB kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to SSB (La) in human serum. It is intended for use as an aid in the diagnosis of Sjögren’s syndrome (SS) and Systemic Lupus Erythematosus (SLE) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument

Source page: https://510kreport.com/device/K250814
Methodology: https://510kreport.com/methodology