510(k) · Cleared
Recalled · 2008Relisa Ena Antibody Screening Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno Concepts, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Jan 31, 1994 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 1994
- Review
- 95 days
- Class
- Class II
- Product code
- LLL
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK935129 Relisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK955603 Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996
- Descendant · 2 generations on · 2 of its ownK972145 Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998
- Descendant · 3 generations on · 0 of its ownK131791 Ifa 40: Hep-20-10Euroimmun US · 2014
- Descendant · 3 generations on · 0 of its ownK060431 Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006
- Descendant · 2 generations on · 0 of its ownK983924 Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc. · 1998
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K955603Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996 · cites it directly4descendants
- K972145Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998 · 2 generations on2descendants
- K131791Ifa 40: Hep-20-10Euroimmun US · 2014 · 3 generations on0descendants
- K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006 · 3 generations on0descendants
- K983924Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935129 | Relisa Ena Antibody Screening Test System | Immuno Concepts, Inc. | 1994 | — |
| +1 | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test System | Immuno Concepts, Inc. | 1996 | — |
| +2 | K972145 | Hep-2000 Fluorescent Ana-RO Test System | Immuno Concepts, Inc. | 1998 | — |
| +3 | K131791 | Ifa 40: Hep-20-10 | Euroimmun US | 2014 | — |
| +3 | K060431 | Anti Rna Polymerase Iii Elisa Kit, Model 7805 | Mbl International Corporation | 2006 | — |
| +2 | K983924 | Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO | Immuno Concepts, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 5 | 0 |
| 1998 | 2 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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? (9)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2008 | Not classified | Z-1045-2009 | Process control | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955603 (Immuno Concepts, Inc., 1996) has gone furthest, with 4 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/K935129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935129: Relisa Ena Antibody Screening Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935129
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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