MS spectrometer cobas® i 601

tandemMS/MSdiagnostic

Overview
The cobas® i 601 analyzer is an integrated, automated LC‑MS/MS clinical analyzer that converts reference mass spectrometry methods into routine, high‑throughput in‑vitro diagnostic workflows. It couples magnetic bead–based automated sample preparation, onboard liquid chromatography and a triple quadrupole mass spectrometer with electrospray ionization (ESI) for quantitative analysis of endogenous and synthetic compounds in human specimens.

Intended use
The cobas® i 601 analyzer is intended for the identification and quantification of naturally occurring and synthetic compounds (e.g., steroids, vitamin D, therapeutic drugs, drugs of abuse) in human specimens using LC‑MS/MS for clinical in‑vitro diagnostic determinations.

Key benefits

• Automated sample‑to‑result workflow to minimize operator hands‑on time.
• Random‑access processing for continuous loading and priority (STAT) handling.
• Paramagnetic particle‑based automated sample preparation for reliable analyte purification.
• Onboard LC with automatic mobile‑phase mixing and multiple parallel LC channels for throughput.
• Triple quadrupole MS with ESI for sensitive, specific detection and quantification.
• Integrated data processing, automated result validation, reporting and LIS connectivity.

Operational and workflow highlights

• Designed for routine core‑lab integration and 24/7 operation.
• Seamless integration with cobas® pro solutions and other cobas analytical units to fit laboratory workflows.
• RFID‑labelled, ready‑for‑use multi‑analyte reagent cassettes to reduce hands‑on reagent handling and improve traceability.
• Step‑by‑step operator guidance, continuous system monitoring and automated maintenance to reduce downtime and enable operation by non‑MS specialists.

Assay menu and development
The cobas® i 601 analyzer is part of the cobas® Mass Spec solution and is complemented by the Ionify® reagents portfolio. A broad assay menu is planned (more than 60 assays in development) covering steroids, vitamin D, therapeutic drug monitoring and drugs of abuse. Assays are provided in RFID‑labelled reagent cassettes for simplified loading and automatic registration.

Components and modular units
The solution architecture includes integrated units such as:

• Sample Supply Unit (SSU) with continuous loading and STAT port — five‑position racks (configurations up to ~300 sample capacity).
• Sample Buffer Unit (SBU) for random access buffering and continuous operation; holds multiple racks.
• Sample Preparation Unit (SPU) — paramagnetic particle purification and automated pre‑treatment for many assays.
• Liquid Chromatography Unit (LCU) — RFID‑labelled ready‑for‑use LC cartridges, automatic mobile‑phase mixing and parallel LC channels.
• Mass Spectrometry Unit (MSU) — triple quadrupole tandem MS with ESI for detection and quantification.

Performance highlights

• High throughput: up to approximately 100 injections per hour (system‑dependent), enabled by parallel LC channels.
• Random‑access continuous operation to reduce turnaround time and increase predictability.
• Large onboard reagent capacity (cooled rotor with 48 reagent positions) and on‑the‑fly reagent loading to minimize interruptions.

Regulatory and traceability
The cobas® i 601 analyzer, Ionify reagents and associated workflows are designed to support IVDR requirements. Assay designs include traceability chains to reference measurement procedures to support consistent inter‑laboratory performance and quality.

Technical specifications

• Commercial name / model: cobas® i 601 analyzer
• Product identifier (internal): INS_6728
• Intended use: Quantitative in‑vitro identification and quantification of endogenous and synthetic compounds in human specimens by LC‑MS/MS.
• Primary technology: Magnetic bead‑based sample preparation + liquid chromatography + triple quadrupole tandem mass spectrometer with ESI.
• Throughput: up to ~100 injections per hour (system‑dependent).
• Reagent management: cooled reagent rotor with 48 positions; multi‑analyte RFID‑labelled reagent cassettes; on‑the‑fly reagent loading.
• LC capacity: automatic onboard mixing and multiple (8) parallel LC channels.
• Sample handling: continuous loading, five‑position racks, SSU and buffer units for random access and STAT handling.
• Automation: full sample‑to‑result automation for many workflows; automated validation, reporting and LIS connectivity.
• Assay menu: Ionify reagents with >60 assays in development (steroids, vitamin D, TDM, drugs of abuse), provided in multi‑analyte reagent cassettes.
• Regulatory: designed for IVDR compliance and traceability to reference methods.
• EAN: 07613336231364
• Manufacturer family / platform: cobas® Mass Spec solution / cobas® pro integrated solutions (integration with cobas ISE neo, cobas c 503, cobas e 801 noted).
• Notes: Manual pre‑treatment may be required for specific assays (e.g., some immunosuppressants, certain free‑drug assays).