510(k) · Cleared
Recalled · Class II · 2012Triage Tox Drug Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · LDP Colorimetry, Acetaminophen
Cleared on Feb 28, 2005 as substantially equivalent to K012745 (Biosite Incorporated, 2002) after a 97-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- LDP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012745 (2002). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK012745 Triage Tox Drug Screen, Catalog #94000Biosite Incorporated · 2002
- This deviceK043242 Triage Tox Drug ScreenBiosite Incorporated · 2005
- Descendant · cites it directly · 1 of its ownK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK200363 Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK080347 Uniscan -Doa SystemTaiwan Unison Biotech, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK060791 Triage Tox Drug Screen, Model 94400Biosite Incorporated · 2006 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019 · cites it directly1descendant
- K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020 · 2 generations on0descendants
- K080347Uniscan -Doa SystemTaiwan Unison Biotech, Inc. · 2008 · cites it directly0descendants
- K060791Triage Tox Drug Screen, Model 94400Biosite Incorporated · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012745 | Triage Tox Drug Screen, Catalog #94000 | Biosite Incorporated | 2002 | — |
| 0 (this device) | K043242 | Triage Tox Drug Screen | Biosite Incorporated | 2005 | — |
| +1 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| +2 | K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020 | — |
| +1 | K080347 | Uniscan -Doa System | Taiwan Unison Biotech, Inc. | 2008 | — |
| +1 | K060791 | Triage Tox Drug Screen, Model 94400 | Biosite Incorporated | 2006 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LDP? 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 LDP device
- #1 K261364 Atellica CH Acetaminophen 2 (ACTM)score 11.7 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K012745 | Triage Tox Drug Screen, Catalog #94000Summary page 1…red: February 22, 2005 B. Product Triage® TOX Drug Screen (K043242) C. Predicate Devices Triage TOX Drug Screen, FDA File Number 510(k) 012745 D. Device Description and Intended Use The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be… | 2002 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K182719 (Quidel Cardiovascular, Inc., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LDP devicesLDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDP
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LDP
Too few LDP 510(k)s in any year since 2007 to give a median.
Recalls per year · LDP
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDP
3in 2025
MAUDE reports naming product code LDP, 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 | 6 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 2 | 5 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Triage ® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043242: Triage Tox Drug Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043242
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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