510(k) · Cleared
ClearedFarrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Cleared on Nov 21, 2006 after a 113-day review. The FDA summary names no predicate by number.
- Decided
- Nov 21, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- LRM
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by 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 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?
The FDA summary names no predicate by 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 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?
This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results 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/K062183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062183: Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062183
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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