510(k) · Cleared
Recalled · Class II · 2014Triage Tox Drug Screen, Model 94400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · DJR Enzyme Immunoassay, Methadone
Cleared on Jun 22, 2006 as substantially equivalent to K973784 (Biosite Incorporated, 1997) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 2002. It has been recalled 5 times.
- Decided
- Jun 22, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- DJR
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K012745 (2002). 3 ancestors in all, the oldest K973784 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012745 | Triage Tox Drug Screen, Catalog #94000 | Biosite Incorporated | 2002 | — |
| −1 | K043242 | Triage Tox Drug Screen | Biosite Incorporated | 2005 | 1 |
| 0 (this device) | K060791 | Triage Tox Drug Screen, Model 94400 | Biosite Incorporated | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DJR? 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 |
|---|---|---|---|
| * | K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug…Summary page 1…: 03/22/06 B. Device Names Triage® TOX Drug Screen C. Predicate Devices Biosite Triage® 8 Panel for Drugs of Abuse [FDA file number K973784] Biosite Triage® TOX Drug Screen [FDA file number K043242] 0. Device Description and Intended Use The Triage®… | 1997 |
| * | K043242 | Triage Tox Drug ScreenSummary page 1…Drug Screen C. Predicate Devices Biosite Triage® 8 Panel for Drugs of Abuse [FDA file number K973784] Biosite Triage® TOX Drug Screen [FDA file number K043242] 0. Device Description and Intended Use The Triage® TOX Drug Screen Methadone assay is a fluorescence immunoassay in… | 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 |
|---|---|---|---|---|
| Feb 5, 2014 | Class II | Z-1214-2014 | Process control | Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP… |
| Jul 12, 2012 | Class II | Z-2460-2012 | Nonconforming Material/Component | Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in… |
| May 14, 2012 | Class II | Z-2039-2012 | Nonconforming Material/Component | A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has… |
| Mar 12, 2010 | Not classified | Z-1446-2012 | Nonconforming Material/Component | The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen. |
| May 28, 2009 | Class II | Z-0029-2013 | Error in labeling | Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K973784.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic…
Read the full statement (196 words)
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
The threshold concentrations are provided below:
Acetaminophen/Paracetamol APAP 5 pg/mL
Amphetamines AMP 1000 ng/mL
Methamphetamines mAMP 1000 ng/mL
Barbiturates BAR 300 ng/mL
Benzodiazepines BZO 300 ng/mL
Cocaine COC 300 ng/mL
Methadone MTD 300 ng/mL
Opiates OPI 300 ng/mL
Phencyclidine PCP 25 ng/mL
THC THC 50 ng/mL
Tricyclic Antidepressants TCA 1000 ng/mL
This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.
A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060791: Triage Tox Drug Screen, Model 94400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060791
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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