510(k) · Cleared
ClearedVarelisa JO-1 Antibodies
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elias U.S.A., Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Dec 22, 1994 after a 118-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 22, 1994
- Review
- 118 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK944173 Varelisa JO-1 AntibodiesElias U.S.A., Inc. · 1994
- 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 · 2 generations on · 1 of its ownK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
- Descendant · 3 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
- K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007 · 2 generations on1descendant
- K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944173 | Varelisa JO-1 Antibodies | Elias U.S.A., Inc. | 1994 | — |
| +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 | — |
| +2 | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| +3 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
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, K053653 (Biomedical Diagnostics (Bmd) SA, 2006) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K944173 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944173: Varelisa JO-1 Antibodies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944173
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026