Identifiers
- 510(k) Number
- DEN220023 FDA 510(k)
- FDA Product Code
- QYD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3115 FDA 510(k)
- Regulation Number
- 862.3115 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Procise ADL is an Adalimumab Assay, a type of immunoassay for the quantitative determination of adalimumab levels in venous serum. It is designed to work with the ProciseDx Analyzer, which detects time-resolved fluorescent signal from both the donor and FRET acceptor emission within the assay. The device is classified as a Clinical Toxicology device. It is used for quantitative immunoassays, providing lab-quality results in real-time.
The Procise ADL assay is supplied for use with the ProciseDx Analyzer and is intended for the quantitative determination of adalimumab levels in patients undergoing treatment. The device has received FDA 510K authorization and is classified as a Class 2 device under the regulation number 862.3115. The assay is for single-use and is designed for use in a clinical setting, with storage and handling instructions not specified in the provided data.
Frequently asked questions
What is the Procise ADL used for?
The Procise ADL is used for the quantitative determination of adalimumab levels in patients undergoing treatment, providing lab-quality results in real-time.
Is the Procise ADL assay for single-use or reuse?
The Procise ADL assay is designed for single-use in a clinical setting.
What type of device is the Procise ADL classified as?
The Procise ADL is classified as a Clinical Toxicology device, specifically a Class 2 device under regulation number 862.3115.
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: ProciseDx, PDF DEN220023 - accessdata.fda.gov, Technology — ProciseDx 2025, PROCISEDX Inc. 5430 Procise ADL - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN220023 | Class II | Active |
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Manufacturer
- Manufacturer
- ProciseDx Inc.
- FDA Applicant
- Procisedx, Inc.
Sources (1)
- FDA 510(k) DEN220023 24 fields · synced Sep 28, 2026