510(k) · Cleared
ClearedGold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Diagnostics · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Jan 28, 2014 as substantially equivalent to K040953 (Aesku, Inc., 2004) after a 265-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jan 28, 2014
- Review
- 265 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040953 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040953 Aeskulisa Ana Hep-2Aesku, Inc. · 2004
- This deviceK131330 Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa…Gold Standard Diagnostics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040953 | Aeskulisa Ana Hep-2 | Aesku, Inc. | 2004 | — |
| 0 (this device) | K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit | Gold Standard Diagnostics | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJM? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040953 | Aeskulisa Ana Hep-2Summary page 1…ame: Anti-Nuclear Antibody ELISA Product Code: LJM 3) Legally marketed device to which the submitter claims equivalence: Aesku, Inc. Aeskulisa ANA HEp-2 k040953. 4) Description of the device: The assay requires a total of 90 minutes incubation time. The test uses antigen coated on mnic… | 2004 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LJM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LJM
265in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJM
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJM
No MAUDE report names LJM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 3 | 265 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 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 | 0 | — | 0 | — |
What is it indicated for?
The Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit is a qualitative assay for the detection of ANAs in human serum. The assay collectively detects in one well ANAs against double stranded DNA (dsDNA), SSA (Ro60 and Ro52), SSB (La), Sm, Sm/RNP, Scl-70, Jo-1, Ribosomal P, and Centromeric antibodies along with sera positive for immunofluorescent HEp-2 ANAs.
The assay is used as an aid in the diagnosis of Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Sjögren's Syndrome, Progressive Systemic Sclerosis, and Polymyositis/Dermatomyositis, and should be used in conjunction with other laboratory tests and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131330: Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131330
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026