Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3115](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3115) → QYD — Adalimumab Assay

# QYD · Adalimumab Assay

_Clinical Toxicology · 21 CFR 862.3115 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/QYD

## Overview

- **Product Code:** QYD
- **Device Name:** Adalimumab Assay
- **Regulation:** [21 CFR 862.3115](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3115)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. It is intended for use in a clinical laboratory as an aid in the management of patients with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) being treated with infliximab.

## Classification Rationale

Class II (Special Controls). The device is classified under 21 CFR 862.3115, Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN220023](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/QYD/DEN220023.md) | Procise ADL | Procisedx, Inc. | Sep 29, 2023 | DENG |

## Top Applicants

- Procisedx, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/QYD](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/QYD)

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