510(k) · Cleared
ClearedQuidel Triage® TOX Drug Screen, 94600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Cardiovascular, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Mar 11, 2020 as substantially equivalent to K182719 (Quidel Cardiovascular, Inc., 2019) after a 26-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Mar 11, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973547 (1998). 13 ancestors in all, the oldest K930529 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK973547 Triage StatmeterBiosite Incorporated · 1998
- 3 generations backK080635 MedtoxscanMedtox Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK130082 Genprime Drugs of Abuse Reader SystemGenprime, Inc. · 2013
- 1 generation backK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- This deviceK200363 Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973547 | Triage Statmeter | Biosite Incorporated | 1998 | — |
| −3 | K080635 | Medtoxscan | Medtox Diagnostics, Inc. | 2009 | 1 |
| −2 | K130082 | Genprime Drugs of Abuse Reader System | Genprime, Inc. | 2013 | — |
| −1 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| 0 (this device) | K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProSummary page 7…Substantial Equivalence Information: 1. Predicate Device Name: Quidel Triage TOX Drug Screen, 94600 2. Predicate 510(k) Number: K182719, Quidel Triage TOX Drug Screen, 94600 3. Comparison with Predicate: Quidel Triage TOX Drug Screen, 94600 510(k)… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below: Abbreviation Analyte Calibrator Cutoff AMP Amphetamines d-Amphetamine 500 ng/mL mAMP Methamphetamines d-Methamphetamine 500 ng/mL BAR…
Read the full statement (170 words)
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:
Abbreviation Analyte Calibrator Cutoff
AMP Amphetamines d-Amphetamine 500 ng/mL
mAMP Methamphetamines d-Methamphetamine 500 ng/mL
BAR Barbiturates Butalbital 200 ng/mL
BZO Benzodiazepines Temazepam 200 ng/mL
COC Cocaine Benzoylecgonine 150 ng/mL
EDDP Methadone Metabolite EDDP 100 ng/mL
OPI Opiates Morphine 300 ng/mL
THC Cannabinoids 11-nor-9-carboxy-Δ9-THC 50 ng/mL
TCA Tricyclic Antidepressants Desipramine 1000 ng/mL
This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200363: Quidel Triage® TOX Drug Screen, 94600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200363
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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