510(k) · Cleared
ClearedIDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostics Systems Limited · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Aug 21, 2026 as substantially equivalent to K962054 (American Laboratory Products Co., Ltd., 1996) and 2 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Aug 21, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922832 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922832 Quanta Lite SS-B ElisaInova Diagnostics, Inc. · 1992
- 1 generation backK141210 Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash…Inova Diagnostics, Inc. · 2015
- This deviceK253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2015 | 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 K253367 EliA CTD 13 Screenscore 12.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K962054 | Orgentec Anti-SS-a (RO) ElisaSummary page 6…LLL - IDS SS-B/La Revvity Proprietary Information Predicate Device ORGENTEC ANTI-SS-A(RO) ELISA (K962054) Device Name IDS SS-A/Ro Device Description The IDS SS-A/Ro kit consists of a reagent cartridge, 2 levels of calibrators, and a… | 1996 |
| * | K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsSummary page 14…uivalence to the predicate devices. Revvity Proprietary Information Predicate Device QUANTA Flash® Ro60 (K141328) Device Name IDS SS-A/Ro 60 kDa Device Description The IDS SS-A/Ro 60 kDa kit consists of a reagent cartridge, 2 levels… | 2015 |
| * | K141210 | Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B ControlsSummary page 22…equivalence to the predicate device. Revvity Proprietary Information Predicate Device QUANTA Flash® SS-B (k141210) Device Name IDS SS-B/La Device Description The IDS SS-B/La kit consists of a reagent cartridge, 2 levels of calibrat… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 22.4 years on median.
- None of the 5 ancestors has a recall.
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. 2026, this device’s year, is highlighted.
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?
The IDS SS-A/Ro test is an automated in vitro diagnostic device intended for the semi-quantitative determination of SS-A/Ro (52 kDa and 60 kDa) IgG autoantibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome (SjS), and Systemic Sclerosis (SSc). The IDS SS-A/Ro 60 kDa test is an automated in vitro…
Read the full statement (180 words)
The IDS SS-A/Ro test is an automated in vitro diagnostic device intended for the semi-quantitative determination of SS-A/Ro (52 kDa and 60 kDa) IgG autoantibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome (SjS), and Systemic Sclerosis (SSc).
The IDS SS-A/Ro 60 kDa test is an automated in vitro diagnostic device intended for the semi-quantitative determination of SS-A/Ro 60 kDa IgG antibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE), and Sjögren’s Syndrome (SjS).
The IDS SS-B/La test is an automated in vitro diagnostic device intended for the semi-quantitative determination of the SS-B/La IgG autoantibodies in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the in the diagnosis of Systemic Lupus Erythematosus (SLE), and Sjögren’s Syndrome (SjS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253817
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026