AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180349 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 AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays. These devices are designed for the qualitative and simultaneous detection of various drugs of abuse in human urine samples.
These tests are available in dip card or cup formats for over-the-counter use. This device has received FDA 510(k) clearance under K180349.
Frequently asked questions
What are the AssureTech Panel Dip and Quick Cup tests used for?
These devices are designed for the qualitative and simultaneous detection of various drugs of abuse in human urine samples. They utilize competitive binding, lateral flow immunochromatographic assay technology to provide results.
Are these tests intended for home or professional use?
The AssureTech Panel Dip and Quick Cup tests are available for over-the-counter use, meaning they are intended for individuals to purchase and use outside of a clinical setting.
What regulatory authorization do these tests have?
These devices have received FDA 510(k) clearance under K180349. This indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate device.
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: AssureTech Panel Dip Test, AssureTech Quick Cup Test (K170049) — FDA ..., AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, AssureTech Panel Dip Tests, AssureTech Quick Cup… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180349 | Class II | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (hangzhou) Co., Ltd.
- FDA Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
Sources (1)
- FDA 510(k) K180349 24 fields · synced Sep 26, 2026