PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
510(k) K242077
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242077 | Date14 Aug 2024 | 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- Withdrawn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
- NFT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pocguide Multi-Drug Test Cup OTC is a competitive binding, lateral flow immunochromatographic assay designed for the qualitative and simultaneous detection of amphetamine in urine samples. This device operates as an over-the-counter diagnostic tool, providing rapid results to identify the presence of amphetamine without the need for laboratory processing.
This test cup is intended for single-use and is supplied as a non-sterile, non-invasive diagnostic device. It is classified under FDA regulation 862.3100 and has received a 510(k) clearance (K242077) as substantially equivalent to a predicate device. The device is intended for use in clinical toxicology settings and requires no special storage conditions beyond those specified in the accompanying instructions.
Other devices from Aicheck Biotech, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PocguideTM Multi-Drug Test Cup OTC used for?
The PocguideTM Multi-Drug Test Cup OTC is a competitive binding, lateral flow immunochromatographic assay designed specifically for the qualitative and simultaneous detection of amphetamine in urine samples. It provides rapid, on-site results to identify the presence of amphetamine without requiring laboratory processing, making it useful in clinical toxicology settings for quick screening.
Is the PocguideTM Multi-Drug Test Cup OTC sterile or non-sterile?
The device is non-sterile by design. It is classified as a non-invasive diagnostic tool intended for single-use, and sterility is not required for its intended purpose. Always follow the included instructions for proper handling and use.
How is the PocguideTM Multi-Drug Test Cup OTC supplied, and is it reusable?
The test cup is supplied as a single-use, non-sterile device in its original packaging. It is not intended for reuse, as reuse could compromise accuracy and introduce contamination risks. Each test cup is designed for one-time use per urine sample.
What regulatory clearance does the PocguideTM Multi-Drug Test Cup OTC hold?
The device has received FDA 510(k) clearance (K242077), classified under regulation 862.3100 as substantially equivalent to a predicate device. It is intended for over-the-counter use in clinical toxicology settings, adhering to FDA guidelines for diagnostic testing.
Do I need special storage conditions for the PocguideTM Multi-Drug Test Cup OTC?
No special storage conditions are required beyond those specified in the accompanying instructions. The device should be stored in its original packaging, protected from extreme temperatures, moisture, and direct sunlight. Check the instructions for any additional handling or expiration details.