# K053175: Ameditech Drugsmartcup

- Pathway: 510(k) (Special)
- Applicant: Ameditech, Inc.
- Decided: Dec 8, 2005 after 24 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup) (2011), 0 descendants of its own

## Recalls of this device
- Mar 18, 2011 · Not classified · Z-2387-2011: Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an F
- Nov 1, 2010 · Not classified · Z-3104-2011: Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared 

## Indications for use
The Ameditech DrugSmartCupTM is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this test are as follows. Test | Calibrator | Cutoff Amphetamine (AMP) | Amphetamine | 1000 Barbiturates (BAR) | Secobarbital | 300 Cocaine metabolite (COC) | Benzoylecgonine | 300 Benzodiazepines (BZO) | Oxazepam | 300 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500 Methamphetamine (MET) | Methamphetamine | 1000 Methadone (MTD) | Methadone | 300 Opiates (OP1300) | Morphine | 300 Opiates (OP[2000) | Morphine | 2000 Oxycodone (OXY) | Oxycodone | 100 Phencyclidine (PCP) | Phencyclidine | 25 Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 Tetrahydrocannabinol (THC) | I l-nor-A9-THC-9-COOH | 50 This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result In order to obtain a confirmed analytical result, a more specific alternatech nical method is needed Gas Chromatography/MassSpectroscopy (GC/MS) is the prerredconfirmation method.

Source page: https://510kreport.com/device/K053175
Methodology: https://510kreport.com/methodology