# K130082: Genprime Drugs of Abuse Reader System

- Pathway: 510(k) (Traditional)
- Applicant: Genprime, Inc.
- Decided: Dec 20, 2013 after 340 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973547 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080635: Medtoxscan, Medtox Diagnostics, Inc. (2009) Summary page 1.

## Most influential descendants
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K200363: Quidel Triage® TOX Drug Screen, 94600 (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K130082
Methodology: https://510kreport.com/methodology