# K040629: Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine

- Pathway: 510(k) (Traditional)
- Applicant: Accu-Stat Diagnostics, Inc.
- Decided: May 5, 2004 after 56 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: 1 generation back to K993852 (2000). 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)
- K993852: First Check Home Drug Test Panel 4, Worldwide Medical Corp. (2000) Summary page 1.
- K003858: Modification to at Home Drug Test, Models 9150, 9068, and 9175, Phamatech (2001) Summary page 1.

## Indications for use
The Accu-Stat TM Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in 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, 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 that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.

Source page: https://510kreport.com/device/K040629
Methodology: https://510kreport.com/methodology