510(k) · Cleared
ClearedLiquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455
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 Dec 12, 2003 as substantially equivalent to K001373 (Bio-Rad, 2000) after a 52-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 12, 2003
- Review
- 52 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001373 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001373 Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363Bio-Rad · 2000
- This deviceK033366 Liquichek Qualitative Urine Toxicology Control, Negative, Model 454…Bio-Rad · 2003
- Descendant · cites it directly · 0 of its ownK052053 Liquichek Qualitative Urine Toxicology Control, Negative, Positive…Bio-Rad · 2005
Most influential descendants
Showing 1 of 1 · See all- K052053Liquichek Qualitative Urine Toxicology Control, Negative, Positive, MinipakBio-Rad · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | Bio-Rad | 2000 | — |
| 0 (this device) | K033366 | Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive… | Bio-Rad | 2003 | — |
| +1 | K052053 | Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak | Bio-Rad | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 Our reading of the summary gave K001973, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Liquichek Qualitative Urine Toxicology Control”. | 2000 |
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 |
|---|---|---|---|
| K052053 | Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak | 2005 | 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 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 Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033366: Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033366
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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