510(k) · Cleared
ClearedQuidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
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 Jun 19, 2019 as substantially equivalent to K130082 (Genprime, Inc., 2013) and 5 other predicates after a 264-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jun 19, 2019
- Review
- 264 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K973547 (1998). 12 ancestors in all, the oldest K930529 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK973547 Triage StatmeterBiosite Incorporated · 1998
- 2 generations backK080635 MedtoxscanMedtox Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK130082 Genprime Drugs of Abuse Reader SystemGenprime, Inc. · 2013
- This deviceK182719 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200363 Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973547 | Triage Statmeter | Biosite Incorporated | 1998 | — |
| −2 | K080635 | Medtoxscan | Medtox Diagnostics, Inc. | 2009 | 1 |
| −1 | K130082 | Genprime Drugs of Abuse Reader System | Genprime, Inc. | 2013 | — |
| 0 (this device) | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K130082 | Genprime Drugs of Abuse Reader SystemSummary page 8…Specific Urine Enzyme Immunoassay Biosite Incorporated Triage TOX Drug Screen Biosite Incorporated Triage Meter 2. Predicate 510(k) Number: K130082, GenPrime Drugs of Abuse (DOA) Reader System K161714, Immunalysis Barbiturates Urine Enzyme Immunoassay K173963,… | 2013 |
| * | K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsSummary page 8…d Triage TOX Drug Screen Biosite Incorporated Triage Meter 2. Predicate 510(k) Number: K130082, GenPrime Drugs of Abuse (DOA) Reader System K161714, Immunalysis Barbiturates Urine Enzyme Immunoassay K173963, DRI Benzodiazepine Assay K151395, Immunalysis EDDP Sp… | 2016 |
| * | K173963 | DRI Benzodiazepine AssaySummary page 8…2. Predicate 510(k) Number: K130082, GenPrime Drugs of Abuse (DOA) Reader System K161714, Immunalysis Barbiturates Urine Enzyme Immunoassay K173963, DRI Benzodiazepine Assay K151395, Immunalysis EDDP Specific Urine Enzyme Immunoassay K043242, Biosite Incorporat… | 2018 |
| * | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…Summary page 8…K130082, GenPrime Drugs of Abuse (DOA) Reader System K161714, Immunalysis Barbiturates Urine Enzyme Immunoassay K173963, DRI Benzodiazepine Assay K151395, Immunalysis EDDP Specific Urine Enzyme Immunoassay K043242, Biosite Incorporated Triage® TOX Drug Screen K973547… | 2015 |
| * | K043242 | Triage Tox Drug ScreenSummary page 8…, Immunalysis Barbiturates Urine Enzyme Immunoassay K173963, DRI Benzodiazepine Assay K151395, Immunalysis EDDP Specific Urine Enzyme Immunoassay K043242, Biosite Incorporated Triage® TOX Drug Screen K973547, Biosite Incorporated Triage® Meter 3. Comparison with Predica… | 2005 |
| * | K973547 | Triage StatmeterSummary page 8…73963, DRI Benzodiazepine Assay K151395, Immunalysis EDDP Specific Urine Enzyme Immunoassay K043242, Biosite Incorporated Triage® TOX Drug Screen K973547, Biosite Incorporated Triage® Meter 3. Comparison with Predicate: Quidel Triage® TOX Drug Screen, 94600: A… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | 2020 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K200363 (Quidel Cardiovascular, Inc., 2020) has gone furthest, with 0 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. 2019, 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?
Quidel Triage® TOX Drug Screen, 94600: 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…
Read the full statement (215 words)
Quidel Triage® TOX Drug Screen, 94600:
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.
Quidel Triage® MeterPro:
The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
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/K182719 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182719
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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