510(k) · Cleared
ClearedLiquichek Urine Toxicology Control, (Levels S1S and S2S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DIF Drug Mixture Control Materials
Cleared on Nov 24, 2004 as substantially equivalent to K022707 (Bio-Rad, 2002) after a 37-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 24, 2004
- Review
- 37 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022707 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022707 Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E…Bio-Rad · 2002
- This deviceK042865 Liquichek Urine Toxicology Control, (Levels S1S and S2S)Bio-Rad · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439 | Bio-Rad | 2002 | — |
| 0 (this device) | K042865 | Liquichek Urine Toxicology Control, (Levels S1S and S2S) | Bio-Rad | 2004 | — |
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 DIF? 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 |
|---|---|---|---|
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 1…valence is Claimed Liquichek Urine Toxicology Control (Levels SlE and S2E) Bio-Rad Laboratories Irvine, California Docket Number: K022707 4.0 Description of Device Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of… | 2002 |
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 no recall.
- 9 other devices also cite its predicate K022707.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 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 Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology enzyme Immunoassay (EIA) screening procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042865: Liquichek Urine Toxicology Control, (Levels S1S and S2S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042865
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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