# K080635: Medtoxscan

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Feb 13, 2009 after 344 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973547 (1998). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973547: Triage Statmeter, Biosite Incorporated (1998) Summary page 1.

## Most influential descendants
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own
- K130082: Genprime Drugs of Abuse Reader System (2013), 2 descendants of its own
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (2023), 1 descendant of its own
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own

## Recalls of this device
- Apr 5, 2013 · Class II · Z-1329-2013: Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

## 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: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine, Opiates, Phencyclidine and THC (Cannabinoids) 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. The 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 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 PCP Phencyclidine (Phencyclidine) 25 ng/mL THC Cannabinoids (1-nor-9-carboxy-Δ9-THC) 50 ng/mL Configurations of the PROFILE®-V MEDTOXScan® Test Devices may consist of any combination of the above listed drug analytes. THE PROFILE®-V MEDTOXScan® Drugs of Abuse Test 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) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. 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/K080635
Methodology: https://510kreport.com/methodology