HIGHTOP Multi-Drug Urine Test Cup
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220685 FDA 510(k)
- FDA Product Code
- NFT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HIGHTOP Multi-Drug Urine Test Cup is a qualitative lateral flow immunochromatographic assay designed for the simultaneous detection of multiple drugs in urine samples. It functions as a competitive binding assay, providing rapid results for substances including amphetamine, buprenorphine, cocaine, methamphetamine, morphine, and other controlled substances listed in the specifications. This device aids in clinical toxicology assessments by enabling quick, on-site screening for drug presence without the need for laboratory processing.
The test cup is supplied as a single-use, non-sterile diagnostic device intended for use in clinical or pre-employment settings. It requires no special storage conditions beyond protection from extreme temperatures and moisture. Authorized for use in the United States under an FDA 510(k) clearance (K220685), the device adheres to regulatory standards for Class II medical devices under 862.3100. Each test cup is pre-packaged and includes all necessary reagents for a single test, ensuring ease of use in point-of-care environments.
Frequently asked questions
What types of drugs can the HIGHTOP Multi-Drug Urine Test Cup detect, and how does it work?
The HIGHTOP Multi-Drug Urine Test Cup is designed to simultaneously detect multiple controlled substances in urine, including amphetamine, buprenorphine, cocaine, methamphetamine, morphine, and others listed in its specifications. It operates as a competitive binding assay, meaning it uses immunochromatography to compare the presence of drugs in the sample to a known standard, providing rapid, on-site results without laboratory processing. This makes it useful for quick clinical toxicology assessments in settings like emergency rooms or pre-employment screenings.
Is the HIGHTOP Multi-Drug Urine Test Cup sterile, and how should it be stored?
The device is non-sterile and intended for single-use only. Storage requires only protection from extreme temperatures and moisture—no refrigeration or specialized conditions are needed. Each test cup is pre-packaged with all necessary reagents for one use, ensuring convenience for point-of-care testing.
What regulatory pathway does the HIGHTOP Multi-Drug Urine Test Cup follow in the U.S., and what class is it assigned?
The device is cleared for use in the United States under an FDA 510(k) pathway (K220685) and is classified as a Class II medical device under regulation number 862.3100. This classification aligns with its role in clinical toxicology, where it aids in rapid, on-site drug detection without requiring laboratory infrastructure.
Are there different models or sizes available for the HIGHTOP Multi-Drug Urine Test Cup?
The data provided does not specify multiple models or sizes for the HIGHTOP Multi-Drug Urine Test Cup. It is described as a single-use, pre-packaged test cup designed for uniform use in detecting multiple drugs in urine samples. If variations exist, they are not detailed in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx ..., PDF Qingdao HIGHTOP Biotech Co., Ltd. ℅ Joe Shia Manager LSI International ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220685 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K220685 24 fields · synced Oct 6, 2026