510(k) · Cleared
ClearedImmuLisa Enhanced Centromere Antibody 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 Mar 11, 2016 after a 275-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 11, 2016
- Review
- 275 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | INOVA QUANTA Lite™ Centromere ELISA Named without a submission number |
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. 2016, 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?
An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-centromere IgG antibodies in human serum as an aid in diagnosis of limited cutanteous systemic sclerosis / CREST in conjunction with other laboratory and clinical findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151559: ImmuLisa Enhanced Centromere Antibody ELISA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151559
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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