Accurate diagnostic test results depend on the performance of the systems used in the clinical laboratory. The Waters family of LC-MS/MS IVD Systems deliver quality, speed, and versatility to ensure accurate test results every time. With Waters LC-MS medical devices, your lab can:
- Achieve greater efficiency with high performance technology
- Meet your unique application needs with a wide range of instrumentation
- Improve confidence in your data
- Customize workflows to adapt to your laboratory and testing requirements
- Integrate seamlessly to a LIMS system
- Comply with 21 CFR Part 820, Quality System Regulation, and ISO 13485:2003
With LC-MS/MS as a powerful analytical technique in your laboratory, you can expand your testing capabilities to provide better patient care.
LC-MS/MS IVD Systems Portfolio FAQs
What types of clinical tests can be performed using Waters LC-MS/MS IVD systems?
Waters LC-MS/MS IVD systems are designed to support a wide range of clinical diagnostic applications that require high precision and specificity. These systems are used for quantifying trace-level analytes such as hormones, vitamins, therapeutic drugs, and biomarkers in complex biological matrices like serum, plasma, or urine. They are also well-suited for multi-analyte routine testing, including panels for endocrinology, toxicology, and metabolic disorders. For neonatal screening, the RenataDX System enables efficient dried blood spot (DBS) analysis. The high sensitivity, wide dynamic range, and method flexibility of Waters LC-MS/MS systems make them a reliable choice for clinical labs aiming to expand their test menu while improving result accuracy and turnaround time. Each system is engineered to align with diagnostic workflows while meeting regulatory requirements for clinical use.
Which system should I choose for low-concentration analyte quantification?
For laboratories focused on quantifying low-abundance analytes with high accuracy, Waters offers several systems optimized for sensitivity. The MassTrak ACQUITY UPLC I-Class PLUS/Xevo TQ Absolute IVD System is ideal for trace analysis due to its ultra-sensitive performance and compact design. For even more demanding workflows involving complex clinical matrices, the Xevo TQ-XS IVD System delivers maximum sensitivity and reproducibility, making it a strong choice for critical applications such as steroid hormone quantification or therapeutic drug monitoring. Both systems offer high throughput, robust performance, and compliance with clinical regulations, allowing labs to confidently generate reliable results even at the lowest concentration levels.
Can these systems integrate with our existing LIMS?
Yes, Waters LC-MS/MS IVD systems are designed to seamlessly integrate with Laboratory Information Management Systems (LIMS) to support efficient clinical workflows. This integration enables automatic data transfer, minimizing manual entry and reducing the risk of transcription errors. Waters' IVD platforms support secure, traceable data handling, which is essential for regulated diagnostic environments. With standardized data outputs and connectivity options, these systems allow clinical labs to maintain compliance while streamlining result reporting and audit readiness. Whether you're upgrading an existing LIMS infrastructure or implementing a new one, Waters systems are equipped to fit into a variety of informatics environments for smooth, end-to-end data management.
