510(k) · Cleared
ClearedVarelisa Recombi Ana Screen Eia, Models 128 48/ 128 96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Nov 12, 1999 after a 56-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Nov 12, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK993108 Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96Pharmacia & Upjohn Co. · 1999
- Descendant · cites it directly · 0 of its ownK083188 Varelisa Recombi Ana Screen, Model 12 596Phadia US, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK050967 Varelisa Recombi CTD Screen, Model 13096Sweden Diagnostics (Germany) GmbH · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993108 | Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999 | — |
| +1 | K083188 | Varelisa Recombi Ana Screen, Model 12 596 | Phadia US, Inc. | 2009 | — |
| +1 | K050967 | Varelisa Recombi CTD Screen, Model 13096 | Sweden Diagnostics (Germany) GmbH | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | — | Varelisa® ANA-8-Screen Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K083188 (Phadia US, Inc., 2009) has gone furthest, with 0 descendants of its own.
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 Screen EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (Systemic Lupus Erythematosus), Scleroderma (Progressive Systemic Sclerosis), MCTD (Mixed Connective Tissue Disease), SS (Sjogren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Screen detects antibodies against d3SDNA, RNP(68kDa, A, C), Sm(B,B',D) SS-A/Ro(52kDa, 60kDa), SS-B/La, Scl-70, Centromere and Jo-1 in a single microwell.
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/K993108 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993108: Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993108
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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