510(k) · Cleared
ClearedImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Mar 31, 2015 after a 186-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 31, 2015
- Review
- 186 days
- Class
- Class II
- Product code
- LLL
- 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 LLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome in conjunction with clinical findings and other laboratory tests. Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of…
Read the full statement (163 words)
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of Sm IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of RNP IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD) in conjunction with clinical findings and other laboratory tests.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K142781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142781: ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP 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/K142781
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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