510(k) · Cleared
ClearedLiquicheck Urine Toxicology Negative Control
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 Mar 10, 1997 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 10, 1997
- Review
- 14 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK970666 Liquicheck Urine Toxicology Negative ControlBio-Rad · 1997
- Descendant · cites it directly · 2 of its ownK012999 Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001
- Descendant · cites it directly · 1 of its ownK050037 Triage Tox Drug Screen ControlsBiosite Incorporated · 2005
- Descendant · 2 generations on · 0 of its ownK060788 Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model…Biosite Incorporated · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK013002 Triage Tox Drug Screen Calibration Verification Controls, Catalog…Biosite Incorporated · 2001
Most influential descendants
Showing 4 of 4 · See all- K012999Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001 · cites it directly2descendants
- K050037Triage Tox Drug Screen ControlsBiosite Incorporated · 2005 · cites it directly1descendant
- K060788Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414Biosite Incorporated · 2006 · 2 generations on0descendants
- K013002Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002Biosite Incorporated · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970666 | Liquicheck Urine Toxicology Negative Control | Bio-Rad | 1997 | — |
| +1 | K012999 | Triage Tox Drug Screen Controls, Catalog #94001 | Biosite Incorporated | 2001 | — |
| +1 | K050037 | Triage Tox Drug Screen Controls | Biosite Incorporated | 2005 | — |
| +2 | K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414 | Biosite Incorporated | 2006 | 2 |
| +1 | K013002 | Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002 | Biosite Incorporated | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012999 (Biosite Incorporated, 2001) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K970666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970666: Liquicheck Urine Toxicology Negative Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970666
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026