Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mu…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182738 FDA 510(k)
- FDA Product Code
- DKZ 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)
This device is a qualitative enzyme immunoassay for the detection of drugs of abuse and adulterants in urine. It includes single and multi-drug test panels, cups, and dipsticks designed to identify substances such as amphetamines, opioids, cocaine, and other controlled compounds, as well as adulterants that may interfere with test results.
The tests are intended for single-use, non-invasive urine screening in clinical toxicology settings. Supplied as individual or multi-drug panels, cups, or dipsticks, they require no specialized equipment beyond the test device itself. The device is not reusable and must be stored under controlled conditions to maintain integrity. Authorized under FDA 510(k) clearance and IVDR compliance, these tests are classified as Class II medical devices under regulatory frameworks.
Frequently asked questions
What types of substances can this device detect in urine samples, and how are the tests structured?
This device detects drugs of abuse such as amphetamines, opioids, and cocaine, along with adulterants that may interfere with test accuracy. The tests come in multiple formats: single-drug and multi-drug rapid test panels, cups, and dipsticks—both for clinical and home use. The panels and cups are designed for multi-substance screening, while dipsticks focus on single substances. Adulteration detection is included in specific panel and cup variants.
Are these tests reusable, and if not, how should they be stored to maintain accuracy?
These tests are explicitly designed for single-use only and are not reusable. To preserve their integrity, they must be stored under controlled conditions as specified by the manufacturer. Proper storage ensures the enzyme immunoassay reagents remain stable and reliable for accurate detection of drugs and adulterants.
What equipment or preparation is required to perform these urine tests?
No specialized equipment is needed beyond the test device itself. The tests are non-invasive and require only urine collection (via a cup or dipstick) and a few minutes for results. The panels and cups are self-contained, while dipsticks may require minimal handling (e.g., dipping into urine). No additional reagents or machinery are required.
How do I know if a test is suitable for clinical or home use, and are there differences between the two?
The device includes both clinical-grade and home-use variants, labeled as 'Rapid Test Panel (Urine)' or 'Home Rapid Test Cup/Dipstick.' Clinical versions are designed for professional settings (e.g., hospitals, labs) and may have stricter handling requirements, while home-use tests prioritize ease of use for individual testing. Both formats detect the same substances but may differ in packaging, instructions, or result interpretation aids.
What regulatory pathways have these tests undergone, and how does that affect their use?
These tests are authorized under FDA 510(k) clearance and comply with the In Vitro Diagnostic Regulation (IVDR) in the EU, classifying them as Class II medical devices. This means they meet stringent performance and safety standards for clinical toxicology use. The regulatory route ensures reliability for professional settings, though home-use variants may follow simplified guidelines for consumer accessibility.
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: single.de - Online Dating, Singlebörse und Partnervermittlung, ⇒ Singles ⇒ Jetzt kostenlos kennenlernen | single.de, Beste Singlebörsen 2026 » 12 Portale im großen Vergleich
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182738 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou AllTest Biotech Co., Ltd.
Sources (2)
- FDA 510(k) K182738 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026