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) → QXT — Infliximab Test System

# QXT · Infliximab Test System

_Clinical Toxicology · 21 CFR 862.3115 · Class 2_

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

## Overview

- **Product Code:** QXT
- **Device Name:** Infliximab Test System
- **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 |
| --- | --- | --- | --- | --- |
| [DEN210056](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/QXT/DEN210056.md) | Procise IFX | Procisedx, Inc. | Sep 29, 2023 | DENG |

## Top Applicants

- Procisedx, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com