510(k) · Cleared
ClearedVarelisa Dsdna Antibodies (Farr Version)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elias U.S.A., Inc. · LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Cleared on Mar 10, 1995 after a 65-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
- Mar 10, 1995
- Review
- 65 days
- Class
- Class II
- Product code
- LRM
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK950031 Varelisa Dsdna Antibodies (Farr Version)Elias U.S.A., Inc. · 1995
- 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 · 2 generations on · 1 of its ownK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
- Descendant · cites it directly · 1 of its ownK041658 Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2004 · Recalled
- 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
- K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007 · 2 generations on1descendant
- K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
- 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) | K950031 | Varelisa Dsdna Antibodies (Farr Version) | Elias U.S.A., Inc. | 1995 | — |
| +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 | — |
| +2 | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| +1 | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | 1 |
| +3 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 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 LRM? 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 LRM devicesLRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRM
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LRM
Too few LRM 510(k)s in any year since 2007 to give a median.
Recalls per year · LRM
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRM
1in 2013
MAUDE reports naming product code LRM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 1 | 28 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 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/K950031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950031: Varelisa Dsdna Antibodies (Farr Version).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950031
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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