# K051966: First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical, LLC
- Decided: Sep 7, 2005 after 49 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: 1 generation back to K040092 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040092: Ameditech Immu Test Drug Screen Panel, Ameditech, Inc. (2004) Summary page 2.
- K042975: Ameditech Immutest Multi-Drug Screen Panel II, Ameditech, Inc. (2004) Summary page 2.
- (no number) Accu-Stat Home Drug Test Cup: named in the summary without a submission number
- (no number) First Check Home Drug Tests: named in the summary without a submission number

## Indications for use
The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at I000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. This device 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) 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 indicated. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided.

Source page: https://510kreport.com/device/K051966
Methodology: https://510kreport.com/methodology