Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153050 FDA 510(k)
- FDA Product Code
- DJG 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)
This device is a lateral flow immunoassay designed for the qualitative detection of drugs and drug metabolites in human urine. It operates as a point-of-care diagnostic tool, providing rapid results for substances such as opiates and other controlled substances at specified cutoff levels. The test follows the principles of enzyme immunoassay, enabling qualitative analysis without complex laboratory equipment.
The device is supplied as a single-use, non-sterile diagnostic kit, intended for use in clinical toxicology settings. It includes both cup and dipcard formats, accommodating 3, 6, or 10-panel configurations for multi-drug screening. Authorized under FDA 510(k) clearance (K153050), it adheres to regulatory standards for Class II medical devices under 21 CFR 862.3650. Storage and handling follow standard in vitro diagnostic guidelines, with no MRI compatibility requirements.
Frequently asked questions
What is the Rapid Single/Multi-drug Test Cup used for?
This device detects drugs and their metabolites in human urine using a lateral flow immunoassay. It provides rapid, qualitative results for substances like opiates and other controlled substances, making it ideal for clinical toxicology settings where quick screening is required. The test follows enzyme immunoassay principles, ensuring accuracy without needing complex lab equipment.
How are the Rapid Single/Multi-drug Test Cup and Dipcard supplied?
The device is supplied as a single-use, non-sterile diagnostic kit. It comes in two formats: a cup format for direct urine sample testing and a dipcard format for immersive testing. Both accommodate multi-panel configurations (3, 6, or 10 panels) for comprehensive drug screening, ensuring flexibility for different clinical needs.
Is the Rapid Single/Multi-drug Test Cup sterile?
No, the device is explicitly labeled as non-sterile. Since it is intended for single-use and designed for point-of-care testing, sterility is not required for its intended application in clinical toxicology. Standard in vitro diagnostic handling practices should be followed to maintain sample integrity.
Can the Rapid Single/Multi-drug Test Cup be reused?
No, the device is designed for single-use only. Reusing the test cup or dipcard could compromise accuracy and introduce contamination risks, which is why it is explicitly labeled as non-reusable. Each test should be used once per patient sample to ensure reliable results.
What storage conditions are required for the Rapid Single/Multi-drug Test Cup?
The device should be stored according to standard in vitro diagnostic guidelines. This typically includes keeping it in a cool, dry place (e.g., 2–30°C) and protecting it from direct sunlight or extreme temperatures. Avoid freezing, as this may affect performance. Always refer to the included instructions for specific storage 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: Leading diagnostic testing service manufacturer - Co-Innovation Biotech ..., Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard, Rapid Single/multi-drug Test Cup And Rapid Single/multi-drug Test ..., Multi Drugs 3 Panels 6 Panels 10 Panels Rapid Test Kit Dipcard
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153050 | Class II | Active |
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Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
- FDA Applicant
- Co-Innovation Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K153050 24 fields · synced Oct 1, 2026