Hamamatsu C11787 Series Immunochromatographic Analyzer
| Brand | Hamamatsu |
|---|---|
| Origin | Japan |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Imported Instrument |
| Model | C11787 |
| Pricing | Available Upon Request |
Overview
The Hamamatsu C11787 Series Immunochromatographic Analyzer is a precision optical detection system engineered for quantitative analysis of lateral flow immunoassays (LFIA). It employs high-sensitivity photometric and fluorometric measurement principles—utilizing calibrated LED excitation sources and spectrally optimized photodiode arrays—to capture reflectance intensity from colored (red/blue chromogenic) test lines and fluorescence emission from labeled conjugates (e.g., europium chelates, quantum dots). Designed for R&D laboratories and QC/QA departments in IVD manufacturing, the instrument delivers reproducible, traceable signal quantification across multiple assay formats without requiring user calibration per test strip. Its optical architecture complies with ISO 13485-aligned design controls and supports method validation under CLIA and FDA 21 CFR Part 820 requirements.
Key Features
- Multi-modal detection capability: simultaneous or independent measurement of absorbance (520–650 nm range) and fluorescence (excitation at 365 nm / emission at 615 nm standard; configurable for alternative wavelengths)
- Dual-operation modes: PC-controlled acquisition (C11787-00/-10/-20) and standalone operation (C11787-50/-60/-70) with integrated monochrome LCD display, membrane keypad, and on-device sample ID registration
- Standardized data export: all measurements saved as UTF-8 encoded CSV files compliant with Excel, LibreOffice Calc, and statistical analysis platforms (e.g., JMP, GraphPad Prism)
- Traceable metrology: factory-calibrated using NIST-traceable color reference standards included with each unit (A10795 verification chart)
- Modular hardware interface: USB 2.0 communication port (A10796 cable supplied); optional RS-232 and analog output interfaces available upon request for integration into automated production lines
- Robust mechanical design: aluminum alloy chassis with ESD-safe surface finish; operating temperature range 15–30 °C, relative humidity ≤70% non-condensing
Sample Compatibility & Compliance
The C11787 series accommodates standard nitrocellulose or polyester-based lateral flow strips (width: 3–5 mm; length: up to 80 mm), including dual-analyte cassettes and multiplexed strip configurations. It supports common conjugate labels: colloidal gold (red), latex beads (blue), and lanthanide-doped nanoparticles (time-resolved fluorescence). All firmware and software modules comply with IEC 62304 Class B for medical device software lifecycle management. Data integrity safeguards include electronic audit trails, user-access levels (admin/operator), and timestamped metadata embedded in exported CSV headers—enabling alignment with FDA 21 CFR Part 11 and EU Annex 11 regulatory expectations for analytical instrumentation used in GMP environments.
Software & Data Management
The bundled PC software (distributed via A10797 CD-ROM) provides instrument control, real-time signal visualization, batch processing, and curve-fitting tools for 4-parameter logistic (4PL) and linear regression models. Raw intensity values are recorded with 16-bit resolution per channel; no proprietary binary formats are used. Software installation follows GLP-compliant procedures documented in the included Installation Qualification (IQ) guide. Exported CSV files contain column headers specifying measurement type (Abs/Fluor), wavelength, exposure time, strip position coordinates, and operator ID—facilitating direct import into LIMS systems or ELN platforms. Version-controlled firmware updates are distributed through Hamamatsu’s secure customer portal, with full revision history and impact assessment documentation.
Applications
- Development and optimization of rapid diagnostic assays for infectious disease biomarkers (e.g., CRP, influenza A/B, SARS-CoV-2 antigens)
- Stability testing of conjugated antibodies and detection reagents under accelerated aging conditions
- In-process quality control during lateral flow strip manufacturing (linearity verification, lot-to-lot consistency checks)
- Reference method validation against ELISA or chemiluminescence platforms in clinical laboratory settings
- Regulatory submission support: generation of raw data packages compliant with ISO 15197:2013 and CLSI EP17-A2 guidelines
FAQ
What types of lateral flow assays can the C11787 analyze?
It supports chromogenic (colloidal gold, dye-labeled latex) and fluorescent (europium, QD-based) immunochromatographic strips, including single-plex and dual-analyte formats.
Is the instrument suitable for regulated manufacturing environments?
Yes—its design, documentation, and data handling protocols align with ISO 13485, FDA 21 CFR Part 820, and Annex 11 requirements for analytical instrumentation used in IVD production.
Can the standalone models (C11787-50 series) operate without a PC?
Yes—they feature an integrated LCD, keypad, and internal memory for sample ID entry, immediate readout, and local CSV file storage on USB flash drives.
Are calibration standards included with shipment?
Each unit ships with a certified color verification chart (A10795), AC adapter (A10795), USB cable (A10796), and software CD-ROM containing IQ documentation and user manuals.
Does Hamamatsu provide technical support for method development?
Yes—application engineers offer remote consultation and on-site protocol optimization services for assay-specific configuration, including threshold setting, background subtraction, and dynamic range calibration.
