510(k) · Cleared
ClearedVarelisa Recombi CTD Screen, Model 13096
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sweden Diagnostics (Germany) GmbH · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Jun 28, 2005 as substantially equivalent to K993108 (Pharmacia & Upjohn Co., 1999) after a 71-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 28, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993108 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993108 Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96Pharmacia & Upjohn Co. · 1999
- This deviceK050967 Varelisa Recombi CTD Screen, Model 13096Sweden Diagnostics (Germany) GmbH · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993108 | Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999 | — |
| 0 (this device) | K050967 | Varelisa Recombi CTD Screen, Model 13096 | Sweden Diagnostics (Germany) GmbH | 2005 | — |
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 |
|---|---|---|---|
| * | K993108 | Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96Summary page 1…Varelisa® ReCombi CTD Screen LJM II 866.5100 Substantial Equivalence to Varelisa® ReCombi ANA Screen (510(k) number: K993108) Varelisa® CTD Screen - New Device 510(k) Submission Section 9. Summary of Safety and Effectiveness Inten… | 1999 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K993108.
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.
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?
The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sj6gren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-I in a single microwell.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050967: Varelisa Recombi CTD Screen, Model 13096.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026