510(k) · Cleared
ClearedLiquichek Anti-Dsdna Control, Model 213
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Cleared on Dec 18, 1998 as substantially equivalent to K813592 (Kallestad Laboratories, Inc., 1982) after a 9-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Dec 18, 1998
- Review
- 9 days
- Class
- Class II
- Product code
- LRM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813592 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK813592 Quantafluor Fluorescent Test ReagentsKallestad Laboratories, Inc. · 1982 · Recalled
- This deviceK984396 Liquichek Anti-Dsdna Control, Model 213Bio-Rad · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813592 | Quantafluor Fluorescent Test Reagents | Kallestad Laboratories, Inc. | 1982 | 2 |
| 0 (this device) | K984396 | Liquichek Anti-Dsdna Control, Model 213 | Bio-Rad | 1998 | — |
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 LRM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K813592 | Quantafluor Fluorescent Test ReagentsSummary page 2…ntigen, Control. Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592 Statement of Intended Use Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassa… | 1982 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K813592.
How does its category compare?
All LRM devicesLRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRM
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LRM
Too few LRM 510(k)s in any year since 2007 to give a median.
Recalls per year · LRM
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRM
1in 2013
MAUDE reports naming product code LRM, 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 | 15 |
| 2008 | 0 | — | 1 | 28 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 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-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA 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/K984396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984396: Liquichek Anti-Dsdna Control, Model 213.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984396
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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