510(k) · Cleared
Recalled · Class II · 2017Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 3, 1997 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 3, 1997
- Review
- 61 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 4
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK973784 Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and…Biosite Incorporated · 1997
- Descendant · cites it directly · 1 of its ownK012396 Ontrak Testcard 9Roche Diagnostics Corp. · 2001
- Descendant · cites it directly · 0 of its ownK060791 Triage Tox Drug Screen, Model 94400Biosite Incorporated · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK051235 ON Trak TestcardVarian, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other… | Biosite Incorporated | 1997 | — |
| +1 | K012396 | Ontrak Testcard 9 | Roche Diagnostics Corp. | 2001 | — |
| +1 | K060791 | Triage Tox Drug Screen, Model 94400 | Biosite Incorporated | 2006 | 5 |
| +2 | K051235 | ON Trak Testcard | Varian, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2017 | Class II | Z-0418-2018 | Nonconforming Material/Component | The recalled lots have demonstrated unexpected false positive THC results. |
| Jan 4, 2012 | Not classified | Z-1130-2012 | Nonconforming Material/Component | Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA. |
| Jul 1, 2011 | Not classified | Z-0521-2012 | Nonconforming Material/Component | The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928. |
| Nov 6, 2008 | Not classified | Z-1088-2009 | Other | The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012396 (Roche Diagnostics Corp., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants - Opiates 2000 (and other forms of the product) is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antidepressants in urine. This test provides only a preliminary test result. A more specific alternate chemical…
Read the full statement (204 words)
The Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants - Opiates 2000 (and other forms of the product) is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antidepressants in urine.
This test provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The tricyclic test is a qualitative screening test. A negative result does not eliminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/mL. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the sum of the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973784: Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973784
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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