510(k) · Cleared
ClearedTriage Tox Drug Screen, Catalog #94000
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 Jan 10, 2002 after a 147-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jan 10, 2002
- Review
- 147 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK012745 Triage Tox Drug Screen, Catalog #94000Biosite Incorporated · 2002
- Descendant · cites it directly · 4 of its ownK043242 Triage Tox Drug ScreenBiosite Incorporated · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK200363 Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK080347 Uniscan -Doa SystemTaiwan Unison Biotech, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK060791 Triage Tox Drug Screen, Model 94400Biosite Incorporated · 2006 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K043242Triage Tox Drug ScreenBiosite Incorporated · 2005 · cites it directly4descendants
- K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019 · 2 generations on1descendant
- K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020 · 3 generations on0descendants
- K080347Uniscan -Doa SystemTaiwan Unison Biotech, Inc. · 2008 · 2 generations on0descendants
- K060791Triage Tox Drug Screen, Model 94400Biosite Incorporated · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012745 | Triage Tox Drug Screen, Catalog #94000 | Biosite Incorporated | 2002 | — |
| +1 | K043242 | Triage Tox Drug Screen | Biosite Incorporated | 2005 | 1 |
| +2 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| +3 | K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020 | — |
| +2 | K080347 | Uniscan -Doa System | Taiwan Unison Biotech, Inc. | 2008 | — |
| +2 | K060791 | Triage Tox Drug Screen, Model 94400 | Biosite Incorporated | 2006 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043242 | Triage Tox Drug Screen | 2005 | 4 |
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, K043242 (Biosite Incorporated, 2005) has gone furthest, with 4 descendants 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® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.
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/K012745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012745: Triage Tox Drug Screen, Catalog #94000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012745
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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