510(k) · Cleared
ClearedVarelisa RNP Antibodies
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · LKO Anti-Rnp Antibody, Antigen And Control
Cleared on Nov 26, 1999 after a 35-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Nov 26, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- LKO
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK993589 Varelisa RNP AntibodiesPharmacia & Upjohn Co. · 1999
- Descendant · cites it directly · 5 of its ownK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
- Descendant · 2 generations on · 2 of its ownK151429 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash…Inova Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK083117 Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1…Phadia US, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK082759 Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay…Phadia US, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006 · cites it directly5descendants
- K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc. · 2016 · 2 generations on2descendants
- K083117Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models…Phadia US, Inc. · 2009 · cites it directly1descendant
- K082759Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO ImmunoassayPhadia US, Inc. · 2009 · cites it directly1descendant
- K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993589 | Varelisa RNP Antibodies | Pharmacia & Upjohn Co. | 1999 | — |
| +1 | K053653 | Fidis Connective 10, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| +2 | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1… | Inova Diagnostics, Inc. | 2016 | — |
| +1 | K083117 | Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay… | Phadia US, Inc. | 2009 | — |
| +1 | K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO… | Phadia US, Inc. | 2009 | — |
| +2 | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 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 LKO? 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 |
|---|---|---|---|
| * | — | Synelisa® U1-snRNP (68 kDa) Antibodies Named without a submission number |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053653 | Fidis Connective 10, Model MX006 | 2006 | 5 |
| K083117 | Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models… | 2009 | 1 |
| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay | 2009 | 1 |
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex… | 2004 | 1 |
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, K053653 (Biomedical Diagnostics (Bmd) SA, 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LKO devicesLKO Anti-Rnp Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKO
Too few LKO 510(k)s in any year since 2007 to give a median.
Recalls per year · LKO
No recall names LKO since 2007.
Adverse event reports per year · LKO
No MAUDE report names LKO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 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 RNP Antibodies EIA kit is designed for the semiquantitative and qualitative determination of RNP antibodies in serum or plasma to aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD).
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/K993589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993589: Varelisa RNP Antibodies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993589
Report an extraction error
Are you the manufacturer?
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