Waters Xevo TQD IVD Triple Quadrupole Mass Spectrometer (Refurbished)

Overview

The Waters Xevo TQD IVD is a purpose-engineered triple quadrupole mass spectrometer designed specifically for in vitro diagnostic (IVD) applications in regulated clinical laboratories. Operating on the principle of tandem mass spectrometry (MS/MS) with electrospray ionization (ESI), it delivers high specificity, quantitative precision, and robust reproducibility for targeted small-molecule analysis—including therapeutic drug monitoring (TDM), newborn screening metabolites, steroid profiling, vitamin D assays, and endogenous biomarkers. Its IVD designation signifies conformance to design controls, documentation standards, and performance verification protocols aligned with ISO 13485, FDA 21 CFR Part 820, and the EU In Vitro Diagnostic Regulation (IVDR 2017/746). The system integrates seamlessly with the Waters I-Class UPLC platform to form a fully validated LC-MS/MS workflow optimized for throughput, method transferability, and audit readiness.

Key Features

• Triple quadrupole architecture with unit-mass resolution in Q1 and Q3, enabling selective reaction monitoring (SRM) and multiple reaction monitoring (MRM) acquisition modes
• LockSpray™ dual electrospray ion source providing real-time internal mass calibration for long-term mass accuracy stability (±0.1 Da over 24 h)
• IVD-labeled Acquity I-Class UPLC modules—including SM-FTN sample manager, BSM binary solvent manager, SO sample organizer, and column manager—configured for GLP/GMP-compliant operation
• Rugged RF-only quadrupole collision cell with nitrogen gas optimization for consistent fragmentation efficiency and low chemical noise
• Integrated roughing pump and vacuum system engineered for stable pressure control and minimal downtime
• Pre-configured MassLynx™ NT 4.2 software with IVD-specific method templates, audit trail logging, and user access controls compliant with FDA 21 CFR Part 11

Sample Compatibility & Compliance

The Xevo TQD IVD supports liquid samples compatible with reversed-phase, hydrophilic interaction (HILIC), and ion-pairing chromatography. It accommodates biological matrices including plasma, serum, urine, dried blood spots (DBS), and cerebrospinal fluid (CSF), with demonstrated linearity across clinically relevant concentration ranges (sub-pg/mL to µg/mL). All hardware components bear IVD markings per manufacturer specifications and are traceable to original Waters production lot records. The refurbished unit undergoes full functional validation per Waters’ IVD service protocol—including detector gain calibration, mass axis alignment, SRM sensitivity verification (e.g., cortisol at ≤5 pg on-column), and carryover assessment (<0.05%). Documentation includes Certificate of Conformance, Installation Qualification (IQ) summary, and Operational Qualification (OQ) report.

Software & Data Management

Controlled via MassLynx NT 4.2 software with integrated QuanLynx™ quantitation engine, the system provides structured data acquisition, processing, and reporting workflows validated for clinical use. Audit trails record all user actions—including method edits, integration parameter changes, and result approvals—with time-stamped, non-erasable entries. Electronic signatures comply with 21 CFR Part 11 requirements when deployed with domain-authenticated Windows Server environments. Raw data files (.raw) are stored in vendor-native format with embedded metadata (instrument parameters, calibration status, operator ID), supporting retrospective reprocessing and regulatory inspection. Optional integration with LIMS platforms is supported via standard ODBC and HL7 interfaces.

Applications

• Therapeutic drug monitoring (e.g., tacrolimus, cyclosporine, sirolimus)
• Newborn screening for amino acids, acylcarnitines, and succinylacetone
• Endocrinology assays (cortisol, aldosterone, testosterone, 25-OH vitamin D2/D3)
• Toxicology screening for opioids, benzodiazepines, and stimulants
• Pharmacokinetic and bioequivalence studies in clinical trial settings
• Method development and transfer between clinical labs under CAP/CLIA or ISO 15189 accreditation

FAQ

Is this instrument eligible for CLIA or CAP accreditation?
Yes—the IVD configuration, documented IQ/OQ, and MassLynx audit trail functionality support compliance with CLIA ’88, CAP Chemistry Checklist, and ISO 15189:2022 requirements.
What documentation is provided with the refurbished system?
A complete package includes Certificate of Conformance, refurbishment report, calibration certificates, IQ summary, OQ report, and electronic copies of user manuals and service bulletins.
Can the system be upgraded to support newer software versions?
MassLynx NT 4.2 is the final validated release for Xevo TQD IVD; no further major software upgrades are offered by Waters for this platform, ensuring long-term stability and regulatory consistency.
Does the 6-month warranty cover parts, labor, and travel?
Yes—the warranty includes onsite labor, replacement parts, and technician travel within North America and Europe; extended service plans are available upon request.
Are consumables and spare parts still available from Waters?
All critical consumables—including ESI probes, collision cell components, and detector assemblies—remain actively supported by Waters Global Service Centers through 2027.