510(k) · Cleared
ClearedQuanta Lite SS-B 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 18, 1992
- Review
- 98 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK922832 Quanta Lite SS-B ElisaInova Diagnostics, Inc. · 1992
- Descendant · cites it directly · 2 of its ownK141210 Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash…Inova Diagnostics, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK123261 Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013
- Descendant · 2 generations on · 0 of its ownK253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
- 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
Most influential descendants
Showing 5 of 5 · See all- K141210Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B ControlsInova Diagnostics, Inc. · 2015 · cites it directly2descendants
- K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US · 2013 · cites it directly1descendant
- K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026 · 2 generations on0descendants
- 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) | K922832 | Quanta Lite SS-B Elisa | Inova Diagnostics, Inc. | 1992 | — |
| +1 | K141210 | Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls | Inova Diagnostics, Inc. | 2015 | — |
| +1 | K123261 | Euroimmun Anti-NRNP/SM Elisa (Igg) | Euroimmun US | 2013 | — |
| +2 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | 2026 | — |
| +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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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, K141210 (Inova Diagnostics, Inc., 2015) has gone furthest, with 2 descendants 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/K922832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922832: Quanta Lite SS-B Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922832
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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