# K091454: Profile-V Medtoxscan Drugs of Abuse Test System

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jul 24, 2009 after 67 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: 3 generations back to K014101 (2002). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 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.
- K060351: Medtox Oxycodone, Medtox Diagnostics, Inc. (2006) Summary page 1.
- K020787: Verdict-II Propoxyphene, Medtox Diagnostics, Inc. (2002). Our reading of the summary gave K020387, FDA’s number for Myallergytest System (Immunetech Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VERDICT-II PROPOXYPHENE”.
- K002331: Profile-ER, Medtox Diagnostics, Inc. (2001) Summary page 1.

## Most influential descendants
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (2023), 1 descendant of its own
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own
- K221550: Evidence MultiSTAT DOA Urine MultiPlex (2023), 0 descendants of its own
- K100023: Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System (2010), 0 descendants of its own

## 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, 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 MEDTOXScan® 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; OPI Opiates (Morphine) 100 ng/mL; BAR Barbiturates (Butalbital) 200 ng/mL; OXY Oxycodone (Oxycodone) 100 ng/mL; BZO Benzodiazepines (Nordiazepam) 150 ng/mL; PCP Phencyclidine (Phencyclidine) 25 ng/mL; COC Cocaine (Benzoylecgonine) 150 ng/mL; PPX Propoxyphene (Norpropoxyphene) 300 ng/mL; MAMP Methamphetamine (d-Methamphetamine) 500 ng/mL; THC Cannabinoids (11-nor-9-carboxy-Δ9-THC) 50 ng/mL; MTD Methadone (Methadone) 200 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 drugs. 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/K091454
Methodology: https://510kreport.com/methodology