# K041221: Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Mamp), Ecstasy

- Pathway: 510(k) (Traditional)
- Applicant: Accu-Stat Diagnostics, Inc.
- Decided: Jul 13, 2004 after 64 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K945610 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card, ACON Laboratories, Inc. (2003) Summary page 3.
- (no number) Phamatech At 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 Accu-Stat MT Drugs of Abuse Home Test Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP), is a screening test for the rapid detection of three to seven of the above listed drugs in a variety of combinations human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

Source page: https://510kreport.com/device/K041221
Methodology: https://510kreport.com/methodology