510(k) · Cleared
ClearedRelsia SS-a/RO & SS/B LA Antibody 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 Apr 19, 1996 as substantially equivalent to K935129 (Immuno Concepts, Inc., 1994) after a 133-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Apr 19, 1996
- Review
- 133 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935129 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935129 Relisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. · 1994 · Recalled
- This deviceK955603 Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK972145 Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK131791 Ifa 40: Hep-20-10Euroimmun US · 2014
- Descendant · 2 generations on · 0 of its ownK060431 Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006
- Descendant · cites it directly · 0 of its ownK983924 Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K972145Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998 · cites it directly2descendants
- K131791Ifa 40: Hep-20-10Euroimmun US · 2014 · 2 generations on0descendants
- K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006 · 2 generations on0descendants
- K983924Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935129 | Relisa Ena Antibody Screening Test System | Immuno Concepts, Inc. | 1994 | 1 |
| 0 (this device) | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test System | Immuno Concepts, Inc. | 1996 | — |
| +1 | K972145 | Hep-2000 Fluorescent Ana-RO Test System | Immuno Concepts, Inc. | 1998 | — |
| +2 | K131791 | Ifa 40: Hep-20-10 | Euroimmun US | 2014 | — |
| +2 | K060431 | Anti Rna Polymerase Iii Elisa Kit, Model 7805 | Mbl International Corporation | 2006 | — |
| +1 | 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 |
|---|---|---|
| 1998 | 2 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935129 | Relisa Ena Antibody Screening Test SystemSummary page 1…able Antinuclear Antibody (21 CFR 866.5100) Legally marketed device with which this device has been shown to be equivalent: RELISA® ENA Antibody Screening Tests System, K935129 Description: This is an enzyme immunoassay for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human ser… | 1994 |
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?
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 | — |
What is it indicated for?
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955603 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955603: Relsia SS-a/RO & SS/B LA Antibody Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955603
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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