# K100023: Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Apr 5, 2010 after 90 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K014101 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System, Medtox Diagnostics, Inc. (2009) Summary page 2.

## Indications for use
The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System consists of the PROFILE®-V MEDTOXScan® Test Devices and the MEDTOXScan® Reader. The PROFILE®-V MEDTOXScan® Test Devices are one-step immunochromatographic tests for the rapid, qualitative detection of one or more of the following in human urine: Amphetamines, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, THC (Cannabinoids), and Tricyclic Antidepressants or their metabolites. The PROFILE®-V MEDTOXScan® Test Devices can only be used with the MEDTOXScan® Reader. The MEDTOX Scan® Reader is an instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Device. PROFILE®-V MEDTOXScan® Test Devices cannot be visually read. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only. It is not intended for use in point-of-care settings. The PROFILE®-V MEDTOXScan® Drugs of Abuse Test System detects drug classes at the following cutoff concentrations: AMP Amphetamine (d-Amphetamine) 500 ng/mL; BAR Barbiturates (Butalbital) 200 ng/mL; BUP Buprenorphine (Buprenorphine) 10 ng/mL; BZO Benzodiazepines (Nordiazepam) 150 ng/mL; COC Cocaine (Benzoylecgonine) 150 ng/mL; MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL; MTD Methadone (Methadone) 200 ng/mL; OPI Opiates (Morphine) 100 ng/mL or 2000 ng/mL; OXY Oxycodone (Oxycodone) 100 ng/mL; PCP Phencyclidine (Phencyclidine) 25 ng/mL; PPX Propoxyphene (Norpropoxyphene) 300 ng/mL; THC (Cannabinoids) (11-nor-9-carboxy-Δ9-THC) 50 ng/mL; TCA Tricyclic Antidepressants (Desipramine) 300 ng/mL. Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed and previously cleared drug. Test Devices will have an opiate cutoff of either 100 ng/mL or 2000 ng/mL. Refer to specific product labeling for the combination of drug tests included on that test device. The PROFILE®-V MEDTOXScan® DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST 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. The MEDTOXScan® Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The MEDTOXScan® Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination.

Source page: https://510kreport.com/device/K100023
Methodology: https://510kreport.com/methodology