510(k) · Cleared
ClearedAlegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific · OBE Anti-Ss-A 52 Autoantibodies
Cleared on May 8, 2026 after a 417-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 8, 2026
- Review
- 417 days
- Class
- Class II
- Product code
- OBE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OBE devicesOBE Anti-Ss-A 52 Autoantibodies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OBE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OBE
Too few OBE 510(k)s in any year since 2007 to give a median.
Recalls per year · OBE
No recall names OBE since 2007.
Adverse event reports per year · OBE
No MAUDE report names OBE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (197 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K250814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250814: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250814
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026