Chembio ProciseDx Analyzer

Description

ProciseDx™ Analyzer is the only FDA-cleared system for therapeutic drug monitoring of Infliximab and Adalimumab. It delivers rapid, quantitative serum results in under 5 minutes - helping clinical labs reduce send-outs, improve workflow, and support informed IBD care decisions.

• FDA-Cleared for Therapeutic Drug Monitoring (TDM): The only FDA-cleared system for quantitative measurement of Infliximab (IFX) and Adalimumab (ADL) drug levels in human serum—supporting therapeutic management in adult and pediatric IBD patients.
• Rapid Turnaround Time: Delivers quantitative results in under 5 minutes from sample insertion—enabling timely clinical decision-making and eliminating the delays of send-out testing.
• Streamlined Workflow for Clinical Labs: Minimal hands-on time (~3 minutes) and no batching required. Simple, standardized protocol fits easily into daily operations with no calibration, no daily maintenance, and no special service contracts.
• Compact, Bench-Top Design: Small footprint allows the ProciseDx Analyzer to fit seamlessly into hospital labs, specialty reference labs, and clinical testing sites without disrupting existing workflows.
• High Precision and Proprietary Technology: Utilizes time-resolved fluorescence energy transfer (TR-FRET) for accurate, reproducible results. Delivers performance comparable to laboratory-developed methods (LDTs) in a validated, FDA-cleared format.
• Supports Both Adult and Pediatric IBD Patients: Validated for use in both populations, ensuring broad clinical applicability across a range of GI care settings.
• Full System Offering: Includes the ProciseDx™ Analyzer and FDA-cleared Procise IFX and ADL assays. Each component is designed to work together as a fully integrated platform.

Specifications

• Type: Clinical Chemistry Analyzer
• Sample Type: Serum
• Shipping Condition: -4°F to +131°F (-20°C to +55°C)
• Voltage: 100/240 V
• Weight (English): 10 lb.