510(k) · Cleared
ClearedLiquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak
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 Aug 9, 2005 as substantially equivalent to K033366 (Bio-Rad, 2003) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 9, 2005
- Review
- 11 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001373 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001373 Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363Bio-Rad · 2000
- 1 generation backK033366 Liquichek Qualitative Urine Toxicology Control, Negative, Model 454…Bio-Rad · 2003
- This deviceK052053 Liquichek Qualitative Urine Toxicology Control, Negative, Positive…Bio-Rad · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | Bio-Rad | 2000 | — |
| −1 | K033366 | Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive… | Bio-Rad | 2003 | — |
| 0 (this device) | K052053 | Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak | Bio-Rad | 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? (2)
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 |
|---|---|---|---|
| * | K033366 | Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455Summary page 1…Equivalence is Claimed Liquichek Qualitative Urine Toxicology Control Bio-Rad Laboratories Irvine, California Docket Number: K033366 4.0 Description of Device Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with… | 2003 |
| * | 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?
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 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 2 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 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/K052053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052053: Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052053
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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