Accu-Stat Home Drug Test Cup for Maijuanna (Thc), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Mamp), Ecstasy
by Accu-Stat Diagnostics, Inc.
510(k) K041221
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041221 | Date13 Jul 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3870
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is an enzyme immunoassay for the rapid qualitative detection of five drugs of abuse—marijuana (THC), cocaine (COC), amphetamine (AMP), methamphetamine (MAMP), and ecstasy—in human urine. It functions as a single-use, point-of-care screening tool to identify the presence or absence of these substances at specified cut-off concentrations.
The Accu-Stat Home Drug Test Cup is intended for non-laboratory use and is supplied as a single-use, non-sterile device. It requires no special storage conditions and is regulated under FDA 510(k) clearance as a Class II medical device (FDA regulation number 862.3870). The test is designed for home or clinical screening purposes and provides results within minutes.
Other devices from Accu-Stat Diagnostics, Inc.
Questions
AI-generated answers, 19 Sep 2026
What substances does the Accu-Stat Home Drug Test Cup detect, and how quickly can I expect results?
The Accu-Stat Home Drug Test Cup detects five drugs of abuse in human urine: marijuana (THC), cocaine (COC), amphetamine (AMP), methamphetamine (MAMP), and ecstasy. It is designed as a rapid, point-of-care screening tool that provides results within minutes, making it suitable for immediate use in home or clinical settings.
Is the Accu-Stat Home Drug Test Cup intended for use in a laboratory, or is it meant for non-laboratory settings like home use?
The Accu-Stat Home Drug Test Cup is explicitly designed for non-laboratory use, including home or clinical screening purposes. It is a single-use, point-of-care device, meaning it is meant for quick, on-site testing rather than formal laboratory analysis.
How is the Accu-Stat Home Drug Test Cup supplied, and does it require any special storage conditions?
The device is supplied as a single-use, non-sterile test cup. It does not require special storage conditions, such as refrigeration or controlled humidity, making it convenient for home or clinical use without additional logistical requirements.
What type of regulatory clearance does the Accu-Stat Home Drug Test Cup have, and how does that affect its use?
The Accu-Stat Home Drug Test Cup holds FDA 510(k) clearance as a Class II medical device under regulation number 862.3870. This clearance confirms it meets FDA standards for safety and effectiveness as a qualitative enzyme immunoassay for detecting drugs of abuse in urine, allowing it to be legally marketed and used for home or clinical screening purposes.
Can the Accu-Stat Home Drug Test Cup be reused, or is it designed for one-time use only?
The Accu-Stat Home Drug Test Cup is explicitly designed for single-use only. This ensures accuracy and hygiene, as reuse could compromise test reliability or introduce contamination risks.