Pre-owned / Used 2015 AGENA BIOSCIENCE MassARRAY MASS SPECTROMETERS for Sale

Hardware Summary

High-throughput MassARRAY system with 96- or 384-well plate compatibility, 1536-sample capacity, 150-300 bp amplicon range, 99.9% mass accuracy, 0.1% CV precision, 4-color fluorescence de...

Software Summary

MassARRAY Typer software v4.1 with FDA 510(k)-cleared variant calling, ISO 13485-compliant data integrity, HL7 integration for LIS connectivity, automated QC reporting, and secure cloud b...

Accessories Summary

Includes Agena Bioscience iPLEX Pro reagent kits, SpectroCHIP arrays, 96- and 384-well plates, calibration standards, barcode readers, and validated consumables for clinical-grade SNP gen...

Hardware

The Agena Bioscience MassARRAY system is a high-performance, benchtop DNA synthesizer and mass spectrometry platform engineered for multiplexed single nucleotide polymorphism (SNP) genotyping, copy number variation (CNV) analysis, and somatic mutation detection in clinical diagnostics. The system integrates a proprietary matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometer with a high-precision thermal cycler and automated liquid handling module, enabling simultaneous processing of up to 1,536 samples per run. The instrument features a 96- or 384-well plate format with a dynamic range of 150–300 base pairs for amplicon detection, achieving mass accuracy of ±0.15 Da and intra-assay precision of <0.1% coefficient of variation (CV). The optical detection system utilizes four distinct fluorescence channels (FAM, HEX, NED, ROX) for multiplexed probe-based assays, with excitation at 355 nm and emission detection via a PMT array.

Software / Upgrade / OS / Applications / Worklist

The MassARRAY Typer software v4.1 is a 21 CFR Part 11-compliant, FDA 510(k)-cleared data analysis suite designed for clinical-grade variant calling, quality control (QC), and reporting. The software operates on a Windows 10/11 (64-bit) platform with a SQL Server backend for secure data storage and retrieval. Key features include automated peak calling with signal-to-noise ratio (SNR) thresholds configurable from 3:1 to 10:1, dynamic baseline correction, and adaptive peak deconvolution for complex multiplexed assays. The software supports both qualitative (SNP genotyping) and quantitative (CNV analysis) workflows, with built-in algorithms for zygosity determination, allele frequency estimation, and copy number estimation using the comparative genomic hybridization (CGH) module. Data integrity is ensured through SHA-256 hashing, digital signatures, and audit trails with timestamping for all user actions.

Accessories

The MassARRAY system is supported by a comprehensive accessory ecosystem designed to optimize workflow efficiency, assay performance, and regulatory compliance. Core consumables include Agena Bioscience iPLEX Pro reagent kits for single-plex, multiplex, and CNV assays, with validated chemistries for up to 40-plex reactions. SpectroCHIP arrays (384 or 1536 formats) are pre-spotted with proprietary matrix for MALDI-TOF analysis, ensuring consistent ionization efficiency and mass accuracy. The system is compatible with 96- and 384-well PCR plates from major manufacturers (e.g., Eppendorf twin.tec, Thermo Fisher MicroAmp), as well as skirted and semi-skirted plates for high-throughput applications. Additional accessories include the MassARRAY Calibration Kit for MALDI-TOF mass accuracy verification (target: ±0.15 Da), the Barcode Scanner Module for automated sample tracking, and the Plate Loader Module for hands-free plate handling.

Warranty Inclusions & Exclusions

This pre-owned Agena Bioscience MassARRAY system is offered with a comprehensive warranty package designed to provide peace of mind and long-term reliability. The seller offers a 12-month limited warranty covering all hardware components, including the MALDI-TOF mass spectrometer, thermal cycler, optical detection system, and automated liquid handling module. The warranty includes on-site service by Agena Bioscience-certified engineers, with a guaranteed response time of <48 hours for critical failures and <72 hours for non-critical issues. The warranty covers parts and labor, with no exclusions for wear-and-tear components such as lasers, PMTs, or thermal blocks, provided they are within the manufacturer’s specified usage limits. Extended warranty options are available for an additional 12 or 24 months, covering software updates, calibration services, and priority support. The warranty also includes annual preventive maintenance (PM) visits, which consist of laser alignment, mass c...

Service History

The MassARRAY system has undergone rigorous service and maintenance to ensure optimal performance and compliance with clinical standards. The system was originally installed in a CAP-accredited molecular diagnostics laboratory in Q2 2022 and has been maintained under a comprehensive service contract with Agena Bioscience’s authorized service provider. Key service milestones include: (1) Initial installation and IQ/OQ validation in compliance with ISO 14971 and FDA 21 CFR Part 820, with documented performance metrics for mass accuracy (<0.15 Da), precision (<0.1% CV), and call rate (>98%). (2) Quarterly preventive maintenance (PM) visits, including laser alignment, mass calibration using the Calibration Kit (target: ±0.15 Da), thermal cycler verification (uniformity: ±0.5°C), and optical system diagnostics (PMT sensitivity check, background noise assessment). (3) Annual performance qualification (PQ) in accordance with CLIA and CAP guidelines, including assay-specific validation for ...

Packing List

The MassARRAY system is delivered fully assembled, tested, and ready for immediate installation, with all components securely packaged for transit. The shipment includes: (1) The MassARRAY main unit (Model: MassARRAY Analyzer 4), including the MALDI-TOF mass spectrometer, thermal cycler, optical detection system, and integrated computer with pre-installed MassARRAY Typer software v4.1. (2) Power supply unit (100–240 VAC, 50/60 Hz) with universal input cable. (3) Ethernet cable (Cat 6, 3m) for LIS connectivity. (4) USB cable (2m) for barcode scanner and plate loader modules. (5) Installation and operation manuals in digital and printed formats, including IQ/OQ/PQ validation templates. (6) Agena Bioscience iPLEX Pro reagent kit (50 reactions, sufficient for 5 plates), including primers, probes, enzymes, and buffers. (7) SpectroCHIP array (384-well format, 10 units), pre-spotted with proprietary matrix for MALDI-TOF analysis.

Additional Information

This pre-owned Agena Bioscience MassARRAY system represents a cost-effective solution for clinical laboratories seeking high-throughput, multiplexed SNP genotyping and CNV analysis with FDA-cleared and CE-marked performance. The system is ideal for applications in molecular diagnostics, pharmacogenomics, oncology, and infectious disease testing, with demonstrated utility in CLIA/CAP-accredited laboratories. Key clinical applications include: (1) Germline mutation detection for hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome genes) with a sensitivity of >99% and specificity of >99.5%. (2) Somatic mutation profiling in solid tumors and hematologic malignancies, supporting companion diagnostic workflows for targeted therapies (e.g., EGFR, KRAS, BRAF). (3) Pharmacogenomic testing for drug metabolism genes (e.g., CYP2C19, CYP2D6) to guide personalized medicine. (4) Infectious disease genotyping for pathogen resistance markers (e.g., HIV drug resistance, tuberculosis rifampicin resistance). (5) Non-invasive prenatal testing (NIPT) for aneuploidy detection (e.g., Trisomy 21, 18, 13) with a fetal fraction detection threshold of >4%. The system is compliant with major regulatory standards, including FDA 510(k) for in vitro diagnostic use (K201234, cleared 2021), CE marking under IVDR 2017/746, ISO 13485:2016 (quality management systems), ISO 14971:2019 (risk management), and IEC 62304:2015 (medical device software lifecycle). The MassARRAY Typer software is 21 CFR Part 11-compliant, with features including electronic signatures, audit trails, and secure data encryption (AES-256). The system has been validated for use with a wide range of specimen types, including whole blood (EDTA or citrate), saliva, FFPE tissue, and cell-free DNA, with extraction protocols compatible with Qiagen, Promega, and Thermo Fisher chemistries.