510(k) · Cleared
ClearedImmulisa Antinuclear Antibody Screen Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Oct 26, 2004 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 26, 2004
- Review
- 182 days
- Class
- Class II
- Product code
- LJM
- 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 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?
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 LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjbgren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), and Scleroderma.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041102: Immulisa Antinuclear Antibody Screen Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026