510(k) · Cleared
ClearedLiquichek Anti-SM Control, Positive, Catalog #115
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LKP Anti-Sm Antibody, Antigen And Control
Cleared on Jan 15, 2003 as substantially equivalent to K984479 (Bio-Rad, 1998) after a 23-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 15, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- LKP
- 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 LKP? 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 LKP device
- #1 K202067 EliA SmDP-Sscore 1.7 · 1 generation · 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 |
|---|---|---|---|
| * | K984479 | Liquichek Anti-SM Control, Eia, Model 208Summary page 1…FR 866.5100 3.0 Device to Which Substantial Equivalence is Claimed LiquichekTMAnti-Sm Control, EIA Bio-Rad Laboratories 510 (k) Number: K984479 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 LKP devicesLKP Anti-Sm Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LKP
Too few LKP 510(k)s in any year since 2007 to give a median.
Recalls per year · LKP
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKP
No MAUDE report names LKP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024219: Liquichek Anti-SM Control, Positive, Catalog #115.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024219
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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