Identifiers
- 510(k) Number
- K193480 FDA 510(k)
- FDA Product Code
- NGL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bioeasy Multi-Drug Test Cup is a rapid diagnostic device designed for the qualitative detection of multiple drugs of abuse in urine specimens. It falls under the classification of Test, Opiates, Over The Counter (OTC) and is intended for point-of-care use in clinical toxicology settings, enabling quick screening for substances such as opioids, stimulants, and other controlled substances.
Supplied as a single-use, non-sterile test cup, the device is regulated under 21 CFR 862.3650 and classified as Class II with special controls. It requires no special storage conditions beyond protection from extreme temperatures and moisture, and its use is authorized via FDA 510(k) clearance (K193480). The device is intended for professional use in clinical toxicology laboratories or emergency settings, adhering to the NGL product code for over-the-counter drug testing.
Frequently asked questions
What types of drugs can the BIOEASY Multi-Drug Test Cup detect in urine samples, and where is it typically used?
The BIOEASY Multi-Drug Test Cup is designed for the qualitative detection of multiple drugs of abuse, including opioids and stimulants, in urine specimens. It is intended for point-of-care use in clinical toxicology settings, such as emergency departments or clinical laboratories, to quickly screen for controlled substances.
Is the BIOEASY Multi-Drug Test Cup sterile, and how should it be stored?
The BIOEASY Multi-Drug Test Cup is supplied as a non-sterile, single-use device. Storage requires only protection from extreme temperatures and moisture—no refrigeration or specialized conditions are needed.
How is the BIOEASY Multi-Drug Test Cup regulated, and what does its FDA clearance mean for users?
The device is regulated under 21 CFR 862.3650 and holds an FDA 510(k) clearance (K193480) with a decision of *Substantially Equivalent*. This means it has been deemed comparable to a legally marketed predicate device and is authorized for professional use in clinical toxicology settings, adhering to over-the-counter drug testing standards (NGL product code).
Are there multiple versions or sizes of the BIOEASY Multi-Drug Test Cup, or is it a single standardized test?
The device is supplied as a single-use test cup without explicit size variations mentioned in the data. However, the provided registration numbers (e.g., 3043127647, 3015821396) suggest multiple variants may exist, likely differing in drug panels or sensitivity thresholds. Contact the manufacturer for specific model details.
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: K193480 - BIOEASY Multi-Drug Test Cup | FDA 510 (k), BIOEASY Multi-Drug Test Cup (K182530) - FDA 510 (k), BIOEASY Multi-Drug Test Cup (K193480) — FDA 510(k) | Innolitics, BIOEASY Multi-Drug Test Cup (K182530) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193480 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Bioeasy Biotechnology Co., Ltd.
Sources (1)
- FDA 510(k) K193480 24 fields · synced Sep 19, 2026