510(k) · Cleared
ClearedVarelisa Recombi Ana Profile, Model 18496
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 Apr 26, 2005 as substantially equivalent to K993109 (Pharmacia & Upjohn Co., 1999) and 1 other predicate after a 46-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 26, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000312 (2000). 3 ancestors in all, the oldest K993109 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000312 | Varelisa SM Antibodies | Pharmacia & Upjohn Co. | 2000 | — |
| −1 | K042629 | Varelisa SM Antibodies, Model 18296 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| 0 (this device) | K050625 | Varelisa Recombi Ana Profile, Model 18496 | Sweden Diagnostics (Germany) GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K993109 | Varelisa Recombi Ana ProfileSummary page 1…eCombi LJM 11 866.5100 ANA Profile Substantial Equivalence to Varelisa® ReCombi ANA Profile (5 10(k) number: 1K993109) Varelisa® Smr Abs (5 10(k) number: K042629) Page 40 Varelisa® ReC… | 1999 |
| * | K042629 | Varelisa SM Antibodies, Model 18296Summary page 1…866.5100 ANA Profile Substantial Equivalence to Varelisa® ReCombi ANA Profile (5 10(k) number: 1K993109) Varelisa® Smr Abs (5 10(k) number: K042629) Page 40 Varelisa® ReCombi ANA Profile - New Device 510(k) Submission Se… | 2004 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
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 ANA Profile EIA kit is designed for the qualitative
determination of eight antinuclear antibodies in human serum or plasma to aid in the
diagnosis of SLE (systemic lupus erythematosus), scleroderma (progressive systemic
sclerosis and CREST syndrome), MCTD (mixed connective tissue disease), SS
(Sj6gren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi
ANA Profile individually detects antibodies against dsDNA, UI RNP (RNP 70
kDa,A,C), SmD, SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, CENP-B and Jo-1.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050625: Varelisa Recombi Ana Profile, Model 18496.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050625
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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