510(k) · Cleared
ClearedLiquichek Urine Toxicology Control (Screen Series)
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 Feb 3, 2004 as substantially equivalent to K021411 (Bio-Rad, 2002) after a 47-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Feb 3, 2004
- Review
- 47 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021411 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK021411 Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462…Bio-Rad · 2002
- This deviceK033924 Liquichek Urine Toxicology Control (Screen Series)Bio-Rad Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK120504 Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek…Bio-Rad Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120504Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…Bio-Rad Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021411 | Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463 | Bio-Rad | 2002 | — |
| 0 (this device) | K033924 | Liquichek Urine Toxicology Control (Screen Series) | Bio-Rad Laboratories, Inc. | 2004 | — |
| +1 | K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine… | Bio-Rad Laboratories, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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 |
|---|---|---|---|
| * | K021411 | Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463Summary page 1…hich Substantial Equivalence is Claimed Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California Docket Number: K021411 4.0 Description of Device Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of… | 2002 |
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 |
|---|---|---|---|
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology… | 2012 | 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?
- Its one ancestor has no recall.
- Of its descendants, K120504 (Bio-Rad Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
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?
Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Levels S1 E, S2E, S1 E Low Opiate and S2E Low Opiate
Liquichek Urine Toxicology Control is intended for use as a 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/K033924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033924: Liquichek Urine Toxicology Control (Screen Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033924
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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