510(k) · Cleared
ClearedLiquichek Anti-SM Control, Eia, Model 208
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 Dec 22, 1998 as substantially equivalent to K954723 (Helix Diagnostics, Inc., 1995) after a 6-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Dec 22, 1998
- Review
- 6 days
- Class
- Class II
- Product code
- LKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954723 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954723 Enzyme Immunoassay Ana Screening Test KitHelix Diagnostics, Inc. · 1995 · Recalled
- This deviceK984479 Liquichek Anti-SM Control, Eia, Model 208Bio-Rad · 1998
- Descendant · cites it directly · 0 of its ownK024219 Liquichek Anti-SM Control, Positive, Catalog #115Bio-Rad · 2003
Most influential descendants
Showing 1 of 1 · See all- K024219Liquichek Anti-SM Control, Positive, Catalog #115Bio-Rad · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954723 | Enzyme Immunoassay Ana Screening Test Kit | Helix Diagnostics, Inc. | 1995 | 6 |
| 0 (this device) | K984479 | Liquichek Anti-SM Control, Eia, Model 208 | Bio-Rad | 1998 | — |
| +1 | K024219 | Liquichek Anti-SM Control, Positive, Catalog #115 | Bio-Rad | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 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 |
|---|---|---|---|
| * | K954723 | Enzyme Immunoassay Ana Screening Test Kit Our OCR of the scanned summary read K854723, FDA’s number for SKD Electrochemical System (Ecs) (Smithkline Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit”. | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024219 | Liquichek Anti-SM Control, Positive, Catalog #115 | 2003 | 0 |
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 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, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies.
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/K984479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984479: Liquichek Anti-SM Control, Eia, Model 208.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984479
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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