510(k) · Cleared
ClearedTriage Tox Drug Screen Controls, Catalog #94001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · DIF Drug Mixture Control Materials
Cleared on Oct 3, 2001 as substantially equivalent to K981590 (Bio-Rad, 1998) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 3, 2001
- Review
- 27 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K903430 (1990). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
- 1 generation backK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
- This deviceK012999 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903430 | Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 | Bio-Rad | 1990 | — |
| −1 | K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology… | Bio-Rad | 1998 | — |
| 0 (this device) | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…Summary page 1…Name Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 ' Class | Product Code: DIF C. Predicate Devices BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230) D. Device Description and Intended Use The Triage® TOX Drug Screen C… | 1998 |
| * | K970666 | Liquicheck Urine Toxicology Negative ControlSummary page 1…lity Control Material (Assayed and Unassayed) 21 CFR 862:3280 ' Class | Product Code: DIF C. Predicate Devices BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230) D. Device Description and Intended Use The Triage® TOX Drug Screen Controls a… | 1997 |
| * | K935230 | Emit Iic Negative Control, Control I and IISummary page 1…CFR 862:3280 ' Class | Product Code: DIF C. Predicate Devices BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230) D. Device Description and Intended Use The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage®… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050037 | Triage Tox Drug Screen Controls | 2005 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050037 (Biosite Incorporated, 2005) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K981590.
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?
The Tnage TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012999: Triage Tox Drug Screen Controls, Catalog #94001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026