510(k) · Cleared
ClearedGenprime Drugs of Abuse Reader System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genprime, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 20, 2013 as substantially equivalent to K080635 (Medtox Diagnostics, Inc., 2009) after a 340-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 340 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973547 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973547 Triage StatmeterBiosite Incorporated · 1998
- 1 generation backK080635 MedtoxscanMedtox Diagnostics, Inc. · 2009 · Recalled
- This deviceK130082 Genprime Drugs of Abuse Reader SystemGenprime, Inc. · 2013
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973547 | Triage Statmeter | Biosite Incorporated | 1998 | — |
| −1 | K080635 | Medtoxscan | Medtox Diagnostics, Inc. | 2009 | 1 |
| 0 (this device) | 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 | — |
| +2 | K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080635 | MedtoxscanSummary page 1…LDJ DEVICE CLASSIFICATION: Class 11 S. PREDICATE DEVICE: PROFILE@-V MEDTOXScan® Drugs of Abuse Test System, (K080635) 6. DEVICE DESCRIPTION: The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | 2019 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182719 (Quidel Cardiovascular, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K080635.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, GenPrime DOA Windows-compatible Software and compatible qualitative immunochromatographic, OS Cup and Split Key Cup (SK Cup), test devices. The GenPrime DOA Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA…
Read the full statement (264 words)
The GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, GenPrime DOA Windows-compatible Software and compatible qualitative immunochromatographic, OS Cup and Split Key Cup (SK Cup), test devices. The GenPrime DOA Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. The GenPrime DOA Reader and compatible DOA test devices qualitatively detect drug classes in human urine at the cutoff concentrations shown below:
OS Cup*
AMP Amphetamine (d-Amphetamine) 500 ng/mL
BAR Barbiturates (Secobarbital) 300 ng/mL
COC Cocaine (Benzoylecgonine) 150 ng/mL
MET Methamphetamine (d-Methamphetamine) 500 ng/mL
THC Marijuana (Delta-9-THC-COOH) 50 ng/mL
SK Cup
AMP Amphetamine (d-Amphetamine) 500 ng/mL
MET Methamphetamine (d-Methamphetamine) 500 ng/mL
MTD Methadone 300 ng/mL
MOP 300 Morphine 300 ng/mL
MOP 2000 Morphine 2000 ng/mL
OXY Oxycodone (Oxycodone) 100 ng/mL
PCP Phencyclidine (Phencyclidine) 25 ng/mL
THC Marijuana (Delta-9-THC-COOH) 50 ng/mL
Configurations of the OS Cup and SK Cup may consist of any combination of the above listed drug analytes associated with the respective cup.
The GenPrime DOA reader system provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
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/K130082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130082: Genprime Drugs of Abuse Reader System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130082
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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