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ATTACHMENT 3
SIDE-BY-SIDE TECHNICAL COMPLIANCE MATRIX
Axion BioSystems Maestro Pro Microelectrode Array (MEA) System – Brand Name or Equal Solicitation Number: ______________________________ Quoter/Contractor Name: ______________________________ Manufacturer: ______________________________ Proposed Product/Model: ______________________________ Manufacturer Part Number: ______________________________
UEI: ______________________________
INSTRUCTIONS TO QUOTERS
The quoter shall complete this matrix and submit it with its quotation.
For each requirement, the quoter shall:
1. State whether the proposed product Complies with the Government requirement;
1. Describe the specific feature, capability, or specification of the proposed product;
1. Identify the page, section, URL, technical data sheet, manual, or other supporting documentation where the Government can verify the information; and
1. Identify and explain any deviation from the stated requirement.
A response consisting solely of “Complies,” “Yes,” “Meets Requirement,” or similar wording without supporting technical information may be considered insufficient.
For a product offered as brand name or equal, the Government will use this matrix and supporting documentation to determine whether the proposed product meets all required salient characteristics.
Failure to demonstrate compliance with a material requirement may result in a rating of Technically Unacceptable.
A. SYSTEM AND GENERAL REQUIREMENTS
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| A1 |
| Equipment Condition |
| One new Microelectrode Array system. Equipment shall be new and complete. |
| A2 |
| Brand Name or Equal |
| Axion BioSystems Maestro Pro MEA System, or equal. |
| A3 |
| System Type |
| High-throughput, non-invasive, label-free bioelectronic assay platform. |
| A4 |
| Electrophysiology |
| System shall provide real-time in-vitro electrophysiological measurement. |
| A5 |
| Impedance Measurement |
| System shall provide integrated impedance measurement capability. |
| A6 |
| 2D Cell Culture Compatibility |
| System shall support 2D monolayer cell cultures. |
| A7 |
| 3D Model Compatibility |
| System shall support 3D biological models, including spheroids and organoids. |
| A8 |
| Neural Cell Applications |
| System shall support applications involving neurons, including iPSC-derived neurons. |
| A9 |
| Cardiomyocyte Applications |
| System shall support applications involving cardiomyocytes. |
| A10 |
| Complete Operational System |
| Quotation shall include all components, accessories, hardware, software, licenses, and other items required for a complete operational system. |
B. RECORDING AND STIMULATION CAPABILITIES
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| B1 |
| Simultaneous Channels |
| Minimum 768 simultaneous recording and stimulation channels. |
| B2 |
| Sampling Rate |
| Minimum sampling rate of 12.5 kHz. |
| B3 |
| Bandwidth |
| Required bandwidth approximately 0.01 Hz – 5 kHz. |
| B4 |
| Voltage Stimulation |
| Stimulation capability up to approximately +/-1.2 V. |
| B5 |
| Current Stimulation |
| Stimulation capability up to approximately +/-250 microamps. |
| B6 |
| Multi-Channel Stimulation |
| Stimulation capability shall be available across all required channels. |
| B7 |
| Recording Technology |
| Technology shall provide performance functionally equivalent to Axion BioCore v4 chip technology. |
C. IMPEDANCE MEASUREMENT
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| C1 |
| Electrode Impedance Dynamic Range |
| Approximately 50 ohms – 5 kohms. |
| C2 |
| MEA Viability Dynamic Range |
| Approximately 5 kohms – 100 kohms. |
| C3 |
| Automatic Monitoring |
| System shall provide automatic integrated impedance monitoring. |
| C4 |
| Real-Time Monitoring |
| Impedance monitoring shall be available in real time. |
| C5 |
| Viability Measurement |
| System shall support MEA viability measurements. |
D. PLATE COMPATIBILITY
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| D1 |
| 6-Well MEA |
| Compatible with 6-well MEA format. |
| D2 |
| 24-Well MEA |
| Compatible with 24-well MEA format. |
| D3 |
| 48-Well MEA |
| Compatible with 48-well MEA format. |
| D4 |
| 96-Well MEA |
| Compatible with 96-well MEA format. |
| D5 |
| 384-Well Impedance |
| Impedance measurement capability up to 384-well format. |
| D6 |
| BioCircuit MEA Compatibility |
| Compatible with BioCircuit MEA plates or functionally equivalent plate technology. |
| D7 |
| CytoView MEA Compatibility |
| Compatible with CytoView MEA plates or functionally equivalent technology. |
| D8 |
| Lumos MEA Compatibility |
| Compatible with Lumos MEA plates or functionally equivalent technology. |
| D9 |
| CytoView-Z Compatibility |
| Compatible with CytoView-Z or functionally equivalent technology. |
| D10 |
| 3D MEA Applications |
| Supports required 3D MEA plate/application capability. |
E. ENVIRONMENTAL CONTROL
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| E1 |
| Integrated Environmental Chamber |
| System shall contain integrated environmental control. |
| E2 |
| Temperature Control |
| Approximately ambient +7 degrees C through 46 degrees C. |
| E3 |
| CO2 Control |
| Approximately 0–10% CO2 control range. |
| E4 |
| Humidity Control |
| Integrated humidity control. |
| E5 |
| External Incubator |
| System shall support experimentation without requiring an external incubator during data acquisition. |
F. PHYSICAL AND ELECTRICAL REQUIREMENTS
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| F1 |
| Physical Footprint |
| Proposed system shall be suitable for laboratory installation. Reference system dimensions: approximately 280 x 452 x 225 mm (W x D x H). |
| F2 |
| System Weight |
| Reference system weight approximately 30.6 lbs / 13.9 kg. Identify proposed system weight. |
| F3 |
| Electrical Power |
| Compatible with approximately 100–240 V AC, 50–60 Hz laboratory power. |
| F4 |
| Power Requirement |
| Identify amperage and any special electrical requirements. |
G. SOFTWARE REQUIREMENTS
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| G1 |
| Integrated Acquisition Software |
| Integrated software for data acquisition. |
| G2 |
| Real-Time Visualization |
| Software shall provide real-time data visualization. |
| G3 |
| Data Analysis |
| Software shall provide data analysis capabilities. |
| G4 |
| Neural Module |
| Neural electrophysiology analysis module or equivalent. |
| G5 |
| Impedance Module |
| Impedance analysis functionality. |
| G6 |
| MEA Viability Module |
| MEA viability functionality or equivalent. |
| G7 |
| Automation |
| System shall provide automation capability. |
| G8 |
| API Capability |
| Identify supported automation/API capability. Reference system supports C#, Python, and MATLAB integration. |
| G9 |
| AxIS Navigator |
| AxIS Navigator or functionally equivalent acquisition/navigation software. |
| G10 |
| AxIS Analysis |
| AxIS Analysis or functionally equivalent analysis software. |
| G11 |
| Software Licenses |
| All software licenses required to operate the system shall be included. |
| G12 |
| Analysis Seats |
| Minimum two analysis-software seats/licenses. |
| G13 |
| License Type |
| Identify whether licenses are perpetual, subscription, node-locked, floating, or other. |
| G14 |
| License Term |
| Identify duration of each software license. |
| G15 |
| Software Updates |
| Describe included software updates/upgrades during warranty period. |
H. COMPUTER AND MONITOR
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Specification / Response |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| H1 |
| Computer |
| Contractor shall provide the computer required to operate the system. |
| H2 |
| Monitor |
| Contractor shall provide required monitor/display. |
| H3 |
| System Compatibility |
| Computer shall meet or exceed manufacturer’s recommended specifications for all included software and hardware. |
| H4 |
| Operating System |
| Identify operating system and version. |
| H5 |
| Processor |
| Identify processor specification. |
| H6 |
| Memory |
| Identify installed RAM. |
| H7 |
| Storage |
| Identify storage capacity and configuration. |
I. CONSUMABLES AND ACCESSORIES
| No. |
| Government Requirement / Salient Characteristic |
| Minimum Government Requirement |
| Contractor Proposed Product / Quantity |
| Supporting Documentation / Page Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| I1 |
| CytoView MEA 48-Well Plates |
| Provide required 48-well MEA plates or equal. |
| I2 |
| CytoView MEA 96-Well Plates |
| Provide required 96-well MEA plates or equal. |
| I3 |
| 3DMap MEA Plates |
| Provide required 3DMap MEA plates or equal. |
| I4 |
| MEA Creator Kit |
| Provide MEA Creator Kit or equal. |
| I5 |
| Required Accessories |
| Include all cables, connectors, adapters, and accessories required for full operation. |
| I6 |
| Additional Consumables |
| Identify all additional consumables included in the quotation. |
J. INSTALLATION AND SYSTEM VALIDATION
| No. |
| Government Requirement |
| Minimum Government Requirement |
| Contractor Proposed Approach / Response |
| Supporting Documentation / Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| J1 |
| Onsite Installation |
| Contractor shall provide onsite installation at FDA/CBER, Silver Spring, Maryland. |
| J2 |
| Hardware Setup |
| Contractor shall install and configure all hardware. |
| J3 |
| Software Installation |
| Contractor shall install all required software. |
| J4 |
| Software Activation |
| Contractor shall activate all required software licenses. |
| J5 |
| Calibration |
| Contractor shall perform required system calibration. |
| J6 |
| Performance Verification |
| Contractor shall verify system performance to manufacturer specifications. |
| J7 |
| Validation Documentation |
| Contractor shall provide written installation/system-validation confirmation. |
| J8 |
| Installation Schedule |
| Installation/validation shall be completed within 30 calendar days after equipment delivery. |
K. TRAINING
| No. |
| Government Requirement |
| Minimum Government Requirement |
| Contractor Proposed Approach / Response |
| Supporting Documentation / Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| K1 |
| Onsite Training |
| Provide onsite user training at FDA/CBER. |
| K2 |
| Duration |
| Up to two days of onsite training. |
| K3 |
| Hardware Operation |
| Training shall cover hardware operation. |
| K4 |
| Acquisition Software |
| Training shall cover AxIS Navigator or equivalent. |
| K5 |
| Analysis Software |
| Training shall cover AxIS Analysis or equivalent. |
| K6 |
| Neural Applications |
| Training shall address neural electrophysiology applications. |
| K7 |
| Organoid Applications |
| Training shall address neural organoid MEA applications. |
| K8 |
| Training Documentation |
| Contractor shall provide attendance or completion documentation. |
| K9 |
| Training Schedule |
| Training shall be completed within 60 calendar days after equipment delivery. |
L. DELIVERY
| No. |
| Government Requirement |
| Minimum Government Requirement |
| Contractor Proposed Response |
| Supporting Documentation / Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| L1 |
| Delivery Schedule |
| Equipment delivery within 90 calendar days after award. |
| L3 |
| Delivery Location |
| FDA/CBER, Building 52/72, Room 3148, 10903 New Hampshire Avenue, Silver Spring, MD 20993. |
| L4 |
| Delivery Coordination |
| Contractor shall coordinate delivery with COR at least five business days in advance. |
| L5 |
| Complete Delivery |
| All equipment and required components shall be delivered complete and undamaged. |
| L6 |
| Packing List |
| Contractor shall provide a complete packing list. |
M. WARRANTY
| No. |
| Government Requirement |
| Minimum Government Requirement |
| Contractor Proposed Warranty |
| Supporting Documentation / Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| M1 |
| Warranty Period |
| Standard manufacturer one-year warranty. |
| M2 |
| Hardware Defects |
| Warranty shall cover hardware defects in design, workmanship, and materials. |
| M3 |
| Parts Coverage |
| Identify parts coverage. |
| M4 |
| Labor Coverage |
| Identify labor coverage. |
| M5 |
| Warranty Start |
| Identify proposed warranty commencement date/event. |
| M6 |
| Warranty Service |
| Describe procedure for requesting warranty service. |
| M7 |
| Technical Support |
| Identify technical support available during warranty period. |
N. OPTION YEAR 1 – PERFORMANCE ASSURANCE / PREVENTIVE MAINTENANCE
| No. |
| Government Requirement |
| Minimum Government Requirement |
| Contractor Proposed Service |
| Supporting Documentation / Reference |
| Complies? Yes/No |
| Contractor Comments / Explanation |
| N1 |
| Maintenance Plan |
| PASPM768PRO-OS onsite performance assurance/preventive maintenance service or equal. |
| N2 |
| Option Duration |
| 12 months. |
| N3 |
| Commencement |
| Option period commences following expiration of standard manufacturer warranty. |
| N4 |
| Onsite PM Visit |
| Minimum one onsite preventive maintenance visit during option period. |
| N5 |
| Parts |
| Required parts included. |
| N6 |
| Labor |
| Required labor included. |
| N7 |
| System Verification |
| Contractor shall verify system operation following maintenance. |
| N8 |
| Service Report |
| Written service report required after onsite preventive maintenance visit. |
| N9 |
| Report Contents |
| Report shall identify services performed, parts replaced, if any, and system status. |
| N10 |
| Report Due Date |
| Service report within 10 business days after onsite visit. |
O. CONTRACTOR TECHNICAL CERTIFICATION
The undersigned certifies that:
1. The information provided in this matrix is complete and accurate;
1. The proposed equipment and services comply with the requirements identified as “Yes”;
1. Any exceptions or deviations have been fully disclosed;
1. Supporting documentation submitted with the quotation accurately describes the equipment proposed;
1. Country-of-origin and place-of-manufacture information is accurate to the best of the quoter’s knowledge; and
1. The quoter understands that the Government may rely upon this information in determining technical acceptability and eligibility for award.
Company Name: __________________________________________ Authorized Representative: __________________________________________ Title: __________________________________________ Signature: __________________________________________ Date: __________________________________________ Telephone: __________________________________________ Email: __________________________________________
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