510(k) · Cleared
ClearedLiquichek Anti-RNP Control, Positive, Catalog #116
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Jan 13, 2003 as substantially equivalent to K984476 (Bio-Rad, 1998) after a 21-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 13, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954723 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LKJ? 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 LKJ device
- #1 K210902 EliA Ro52, EliA Ro60score 4.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K984476 | Liquichek Anti-RNP Control, Eia, Model 207Summary page 1…R 866.5100 3.0 Device to Which Substantial Equivalence is Claimed LiquichekTMAnti-RNP Control, EIA Bio-Rad Laboratories 510 (k) Number: K984476 4.0 Description of Device This product is prepared from human serum with added preservatives. The contr… | 1998 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, 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 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Liquichek Anti-RNP Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of ribonucleoprotein (RNP) autoantibodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024223 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024223: Liquichek Anti-RNP Control, Positive, Catalog #116.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024223
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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