Sources_Sought_Notice_Optical_Microscope_CDRH-2026-134025.docx

SOURCES SOUGHT NOTICE

Upright Bright-Field Hyperspectral Imaging Microscope System

DISCLAIMER:

This Sources Sought Notice is issued solely for market research and planning purposes. It does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), nor does it oblige the Government to any future contract. The Government will not reimburse respondents for any costs incurred in response to this notice.

1. Introduction The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Imaging, Diagnostics and Software Reliability (DIDSR) is conducting market research to identify small business concerns capable of providing an upright bright-field hyperspectral imaging microscope system. The requirement includes the delivery of a newly manufactured, fully integrated microscope system capable of serving as a platform for hyperspectral imaging microscopy research, including motorized XY and piezo-based Z stage control, programmable application program interfaces (APIs), autofocusing independent of camera acquisition, fiber optic light guide compatibility, and a high-resolution, high-speed, low-noise camera. The system will support OSEL researchers in developing bench testing methods for evaluating the safety and effectiveness of digital pathology devices.

The system shall be delivered to the FDA facility located in Silver Spring, Maryland, within six (6) weeks of contract award. A one-year warranty period shall commence upon Government acceptance. This Sources Sought Notice is issued for informational and planning purposes only and is intended to gather capability statements and industry feedback to support acquisition strategy development, including potential small business set-aside considerations in accordance with FAR Part 19.

2. Scope of Work (Summary) The anticipated requirement includes the following major areas of support:

1. Supply and delivery of a newly manufactured upright, bright-field, transmissive light microscope system configured as a platform for hyperspectral imaging, including all required components, accessories, and supporting equipment

1. Motorized XY stage supporting standard 1"x3" glass slides, with joystick and software API control, including full API documentation for custom software development

1. Motorized piezo-based Z (focus) stage with joystick and software API control, including full API documentation for custom software development

1. Autofocusing capability that operates independently from the camera acquisition process

1. Illumination subsystem including a white light source and support for external light sources delivered via fiber optics light guide

1. Objective turret supporting two (2) or more objectives simultaneously and compatible with Zeiss M27-threaded objectives

1. Condenser supporting Kohler illumination with a numerical aperture (NA) of 0.55 or greater

1. One (1) high-resolution, high-speed, high-quantum-efficiency, low-noise camera, with optical port(s) for mounting external cameras

1. One-year service support and warranty coverage commencing upon system acceptance

1. Delivery of user manuals, including XY stage, Z stage, and camera APIs, in electronic or paper form

3. Equipment Summary The Contractor shall furnish a complete upright bright-field hyperspectral imaging microscope system with all required components and accessories necessary for full operational capability. The system shall be newly manufactured and shall meet, at a minimum, the following technical requirements:

1. Frame: Upright, bright-field, transmissive light microscope with integrated digital camera capability for specimen image capture

1. Illumination: White light source; external light source input via fiber optics light guide

1. Objective Turret: Supports two (2) or more objectives simultaneously; compatible with Zeiss M27-threaded objectives

1. Condenser: Supports Kohler illumination; numerical aperture (NA) of 0.55 or greater

1. XY Stage: Supports nominal 1"x3" glass slides; motorized with joystick and API control; API and documentation included

1. Z Stage: Motorized piezo-based for high-precision Z-dimension control; joystick and API control; API and documentation included

1. Autofocus: Independent of camera/image acquisition process

1. Camera: One (1) high-resolution, high-speed, high-quantum-efficiency, low-noise camera; optical port(s) for external camera mounting

1. Power: US standard 120V@60Hz AC

1. Warranty: Minimum one (1) year service support and warranty

1. Installation: On-site installation not required

1. Training: Optional

1. Control Computer: Optional

4. Salient Characteristics The microscope system shall meet all of the following salient characteristics. Offerors shall confirm compliance with each characteristic and provide supporting documentation (e.g., manufacturer specification sheets) as part of their response.

4.1 Frame

1. The system shall be an upright, bright-field, transmissive light microscope

1. The system shall include an integrated digital camera port for specimen image capture

4.2 Illumination

1. The system shall include a broadband white light source for transmitted light illumination

1. The system shall include an input port for external light sources delivered via a fiber optics light guide, to support hyperspectral and multispectral illumination configurations

4.3 Objective Turret

1. The objective turret shall support two (2) or more objectives simultaneously

1. The objective turret shall be compatible with Zeiss M27-threaded objectives to allow use of existing Government-owned Zeiss objectives

4.4 Condenser

1. The condenser shall support Kohler illumination for uniform, controlled specimen illumination

1. The condenser numerical aperture (NA) shall be 0.55 or greater

4.5 XY Stage

1. The XY stage shall accommodate nominal 1"x3" (25mm x 75mm) standard glass slides

1. The XY stage shall be motorized and controllable both manually via joystick and programmatically via a software application program interface (API)

1. The XY stage control API and full technical documentation shall be provided to enable custom software development by Government personnel

4.6 Z (Focus) Stage

1. The Z-dimension control shall incorporate a motorized piezo-based Z stage for high-precision focus control

1. The piezo Z stage shall be motorized and controllable both manually via joystick and programmatically via a software API

1. The Z stage control API and full technical documentation shall be provided to enable custom software development by Government personnel

4.7 Autofocus

1. The system shall include an autofocus capability that operates independently from the image/camera acquisition process (i.e., autofocus shall function without the camera acquiring images)

4.8 Camera

1. The system shall include one (1) high-resolution, high-speed, high-quantum-efficiency, low-noise camera for specimen image capture

1. The system shall include one (1) or more optical port(s) for mounting additional external cameras

4.9 Power

1. The system shall operate on US standard 120V at 60Hz AC power supply

4.10 Warranty and Delivery

1. The system shall include a minimum one (1) year service support and warranty commencing upon Government acceptance

1. Delivery shall be completed within six (6) weeks of contract award to the designated FDA facility in Silver Spring, Maryland; shipping costs shall be included in the offer

4.11 Documentation

1. User manuals, including full API documentation for the XY stage, Z stage, and camera, shall be provided in electronic or paper form

5. Response Requirements Interested large and small businesses should submit a Capability Statement that includes the following:

1. Company name, address, Unique Entity Identifier (UEI), and CAGE Code

1. Point of contact name, title, phone number, and email address

1. Business size and any applicable socioeconomic classifications (e.g., 8(a), HUBZone, SDVOSB, WOSB, EDWOSB)

1. Summary of relevant experience providing analytical laboratory instrumentation, specifically optical microscopy systems or comparable precision scientific imaging equipment, including delivery and integration

1. Demonstrated capability to provide motorized stage systems with software API control in laboratory or federal environments

1. Experience providing service agreements and warranty coverage for complex scientific instrumentation

1. Description of technical capability to meet or exceed the performance requirements outlined in the Statement of Work, including motorized stage API functionality, piezo-based Z-stage precision, autofocus independence, and hyperspectral imaging platform compatibility

1. Statement indicating whether the company can perform at least 51% of the work under a small business set-aside, in accordance with FAR 52.219-14

1. List of applicable contract vehicles (e.g., GSA MAS, OASIS, NIH NITAAC, or agency-specific IDIQs)

Respondents are encouraged to include any recent, relevant past performance and to highlight specialized qualifications or technical expertise that align with the scope of this requirement.

Responses should be limited to no more than 10 pages, excluding cover page and attachments, and submitted in PDF or Word format.

6. Submission Instructions Submit responses electronically via email to:

Contract Specialist: Freshta Javid – Freshta.Javid@fda.hhs.gov

Subject Line: Sources Sought – Upright Bright-Field Hyperspectral Imaging Microscope System – CDRH-2026-134025

Due Date: April 30, 2026, 10:00 AM (Eastern Time)