510(k) · Cleared
ClearedQuanta Lite SM Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Sep 18, 1992 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 18, 1992
- Review
- 98 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK922831 Quanta Lite SM ElisaInova Diagnostics, Inc. · 1992
- Descendant · cites it directly · 1 of its ownK123261 Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013
- Descendant · cites it directly · 1 of its ownK123593 Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators…Inova Diagnostics, Inc. · 2013
- 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 · 2 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK140224 Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013 · cites it directly1descendant
- K123593Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…Inova Diagnostics, Inc. · 2013 · cites it directly1descendant
- 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 · 2 generations on0descendants
- K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922831 | Quanta Lite SM Elisa | Inova Diagnostics, Inc. | 1992 | — |
| +1 | K123261 | Euroimmun Anti-NRNP/SM Elisa (Igg) | Euroimmun US | 2013 | — |
| +1 | K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash… | Inova Diagnostics, Inc. | 2013 | — |
| +1 | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | 1 |
| +2 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
| +2 | K140224 | Euroimmun Euroline Ena Profile 9AG (Igg) | Euroimmun US | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 LLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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, K123261 (Euroimmun US, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K922831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922831: Quanta Lite SM Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922831
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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