Deepblue Multi-Drug Urine Test Cup
by Anhui Deepblue Medical Technological Co., Ltd.
510(k) K250803
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250803 | Date15 Apr 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- 510(k) Number
- FDA Product Code
- NGL
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3650
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Deepblue Multi-Drug Urine Test Cup is a rapid qualitative immunoassay device designed for the preliminary detection of multiple drugs in urine samples. It falls under the classification of over-the-counter (OTC) opiate tests and is intended for use in clinical toxicology assessments, providing qualitative results for drug presence without quantifying concentrations.
This device is supplied as a single-use, non-sterile diagnostic test intended for home or clinical use. It is classified under FDA regulation 862.3650 and received a Substantially Equivalent (SESE) 510(k) clearance in April 2025. The test cups are packaged individually and require no special storage conditions beyond protection from extreme temperatures and moisture. No MRI safety considerations apply, as the device is not intended for use in MRI environments.
Questions
AI-generated answers, 19 Sep 2026
What types of drugs can the Deepblue Multi-Drug Urine Test Cup detect, and is it suitable for quantifying drug concentrations?
The Deepblue Multi-Drug Urine Test Cup is a rapid qualitative immunoassay designed for preliminary detection of multiple drugs in urine samples. It provides qualitative results indicating the presence or absence of drugs but does not quantify concentrations. This makes it useful for screening purposes in clinical toxicology assessments, such as identifying potential drug use without measuring exact levels.
Is the Deepblue Multi-Drug Urine Test Cup intended for single-use only, and if so, how should it be stored?
Yes, the Deepblue Multi-Drug Urine Test Cup is explicitly designed for single-use only. It is non-sterile and does not require specialized storage conditions beyond protecting it from extreme temperatures and moisture. Individual packaging ensures each test remains uncontaminated until use.
Can this device be used in environments where MRI machines are present, and what are the safety considerations?
The Deepblue Multi-Drug Urine Test Cup is not intended for use in MRI environments, and no MRI safety considerations apply. Since it is a small, non-metallic diagnostic device, it is not designed for or compatible with magnetic resonance imaging settings, so it should not be used in such areas.
What regulatory pathway was followed for the Deepblue Multi-Drug Urine Test Cup, and what does this mean for its use?
The Deepblue Multi-Drug Urine Test Cup received a Substantially Equivalent (SESE) 510(k) clearance from the FDA in April 2025, following a traditional review pathway. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed for its intended use in clinical toxicology assessments, including both home and clinical settings.
Are there different models or sizes available for the Deepblue Multi-Drug Urine Test Cup, and how are they packaged?
The Deepblue Multi-Drug Urine Test Cup is supplied as a single-use device, with no mention of multiple models or sizes in the provided data. Each test cup is packaged individually, ensuring ease of use and sterility for one-time testing. The packaging does not require refrigeration or special handling beyond protecting it from environmental extremes.