510(k) · Cleared
ClearedFidis Dsdna
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics (Bmd) SA · LSW Anti-Dna Antibody, Antigen And Control
Cleared on May 2, 2006 after a 77-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- May 2, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- LSW
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 LSW? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950011 | FDA’s K950011 is Cohort (TM) Anterior Plate System (Aps) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
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 LSW devicesLSW Anti-Dna Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSW
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LSW
Too few LSW 510(k)s in any year since 2007 to give a median.
Recalls per year · LSW
No recall names LSW since 2007.
Adverse event reports per year · LSW
1in 2019
MAUDE reports naming product code LSW, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 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 FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA)
The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests.
The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyzer, software and washer.
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/K060380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060380: Fidis Dsdna.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060380
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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