510(k) · Cleared
ClearedQuanta Lite SS-a 52 Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · OBE Anti-Ss-A 52 Autoantibodies
Cleared on Apr 4, 2007 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Apr 4, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- OBE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK063565 Quanta Lite SS-a 52 ElisaInova Diagnostics, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK141655 Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash…Inova Diagnostics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK210902 EliA Ro52, EliA Ro60Phadia AB · 2022
- Descendant · cites it directly · 0 of its ownK140224 Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014
Most influential descendants
Showing 4 of 4 · See all- K141655Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsInova Diagnostics, Inc. · 2015 · cites it directly2descendants
- K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K210902EliA Ro52, EliA Ro60Phadia AB · 2022 · 2 generations on0descendants
- K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063565 | Quanta Lite SS-a 52 Elisa | Inova Diagnostics, Inc. | 2007 | — |
| +1 | K141655 | Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls | Inova Diagnostics, Inc. | 2015 | — |
| +2 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
| +2 | K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022 | — |
| +1 | K140224 | Euroimmun Euroline Ena Profile 9AG (Igg) | Euroimmun US | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBE? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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, K141655 (Inova Diagnostics, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OBE devicesOBE Anti-Ss-A 52 Autoantibodies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OBE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OBE
Too few OBE 510(k)s in any year since 2007 to give a median.
Recalls per year · OBE
No recall names OBE since 2007.
Adverse event reports per year · OBE
No MAUDE report names OBE 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 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 | 1 | — | 0 | — |
What is it indicated for?
The QUANTA LiteTM SS-A 52 ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063565: Quanta Lite SS-a 52 Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063565
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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