510(k) · Cleared
ClearedLiquichek Urine Toxicology Control (Level C1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · DIF Drug Mixture Control Materials
Cleared on Apr 29, 2005 as substantially equivalent to K033404 (Bio-Rad, 2003) after a 44-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Apr 29, 2005
- Review
- 44 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903430 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
- 3 generations backK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
- 2 generations backK021384 Liquichek Urine Toxicology Control Levels C1-C4, Models…Bio-Rad · 2002
- 1 generation backK033404 Liquichek Urine Toxicology Control (Confirmatory Series)Bio-Rad · 2003
- This deviceK050682 Liquichek Urine Toxicology Control (Level C1)Bio-Rad Laboratories, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903430 | Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 | Bio-Rad | 1990 | — |
| −3 | K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology… | Bio-Rad | 1998 | — |
| −2 | K021384 | Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444 | Bio-Rad | 2002 | — |
| −1 | K033404 | Liquichek Urine Toxicology Control (Confirmatory Series) | Bio-Rad | 2003 | — |
| 0 (this device) | K050682 | Liquichek Urine Toxicology Control (Level C1) | Bio-Rad Laboratories, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K033404 | Liquichek Urine Toxicology Control (Confirmatory Series)Summary page 2…ine Toxicology Control (Level C1) claims substantial equivalence to the Liquichek Urine Toxicology Control (Level Cl) currently in commercial distribution (K033404). The new Liquichek Urine Toxicology Control contains MDMA, MDA and MDEA and the predicate device does not. Table 1. Simi… | 2003 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
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 confirmatory procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050682 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050682: Liquichek Urine Toxicology Control (Level C1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050682
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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