510(k) · Cleared
Recalled · Class II · 2019Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414
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 Jul 10, 2006 as substantially equivalent to K050037 (Biosite Incorporated, 2005) after a 109-day review. Its family tree reaches back 4 generations to 1990. It has been recalled 2 times.
- Decided
- Jul 10, 2006
- Review
- 109 days
- Class
- Class I
- Product code
- DIF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903430 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK903430 Liquichek CK/LD Isoenzyme Control; Levels 1 and 2Bio-Rad · 1990
- 3 generations backK981590 Liquichek Urine Toxicology Control Level C1, Liquichek Urine…Bio-Rad · 1998
- 2 generations backK012999 Triage Tox Drug Screen Controls, Catalog #94001Biosite Incorporated · 2001
- 1 generation backK050037 Triage Tox Drug Screen ControlsBiosite Incorporated · 2005
- This deviceK060788 Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model…Biosite Incorporated · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903430 | Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 | Bio-Rad | 1990 | — |
| −3 | K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology… | Bio-Rad | 1998 | — |
| −2 | K012999 | Triage Tox Drug Screen Controls, Catalog #94001 | Biosite Incorporated | 2001 | — |
| −1 | K050037 | Triage Tox Drug Screen Controls | Biosite Incorporated | 2005 | — |
| 0 (this device) | K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414 | Biosite Incorporated | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K050037 | Triage Tox Drug Screen ControlsSummary page 1…21 CFR 862.3280 Class I Product Code: DIF C. Predicate Devices Biosite Triage® TOX Drug Screen Controls (K050037) D. Device Description and Intended Use The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2019 | Class II | Z-1552-2020 | Software Manufacturing/Software Deployment | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and… |
| Sep 23, 2013 | Class III | Z-0053-2014 | Under Investigation by firm | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 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?
The Triatge TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test perlbrmance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060788: Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060788
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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