# K040327: Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc)

- Pathway: 510(k) (Traditional)
- Applicant: Accu-Stat Diagnostics, Inc.
- Decided: Apr 19, 2004 after 69 days
- Product code: MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter)
- Device class: U
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) First Check Home Drug Test for THC (Marijuana): named in the summary without a submission number
- (no number) Phamatech At Home Drug Test for Marijuana: named in the summary without a submission number
- (no number) First Check Home Drug Test for Marijuana and Cocaine: named in the summary without a submission number

## Most influential descendants
- K050936: ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine (2005), 0 descendants of its own

## Indications for use
The Accu-StatTM Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is 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 THC or its 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. The Accu-StatTM Home Drug Test for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is 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 either THC, COC (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/K040327
Methodology: https://510kreport.com/methodology