510(k) · Cleared
ClearedThe Aptus (Automated) Applications of the DS Dna Elisa Test System Linked Immunosorbent Assay (Elisa)for the Det
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Cleared on Nov 18, 1998 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 18, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- LRM
- 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 LRM? 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 LRM devicesLRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRM
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LRM
Too few LRM 510(k)s in any year since 2007 to give a median.
Recalls per year · LRM
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRM
1in 2013
MAUDE reports naming product code LRM, 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 | 15 |
| 2008 | 0 | — | 1 | 28 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 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 | 0 | — | 0 | — |
What is it indicated for?
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983422: The Aptus (Automated) Applications of the DS Dna Elisa Test System Linked Immunosorbent Assay (Elisa)for the Det.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983422
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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