RFI- VIDAS KUBE.pdf

Request for Information (RFI)

VIDAS KUBE Systems for FDA Office of Regulatory Testing and Surveillance (ORTS) Laboratory Network

SOLICITATION INFORMATION

Solicitation Number: FDA-SS-26-132814 Posted Date: 3/3/26 Response Date: 3/10/26 Classification Code: NAICS 334516 - Analytical Laboratory Instrument Manufacturing Set Aside: [To be determined]

PURPOSE

The U.S. Food and Drug Administration (FDA) is issuing this Request for Information (RFI) to identify potential sources capable of providing VIDAS KUBE systems to replace discontinued VIDAS systems currently used across the Office of Regulatory Testing and Surveillance (ORTS) laboratory network. This RFI is issued for market research and planning purposes only and does not constitute a solicitation or a commitment by the Government to issue a solicitation or award a contract.

BACKGROUND

The ORTS laboratory network performs scientific testing on FDA-regulated products. To ensure testing results are competent and suitable for regulatory purposes, ORTS laboratories utilize validated methods including rapid screening protocols for various pathogens of interest including Salmonella spp. and Listeria spp. All ORTS laboratories currently use the VIDAS system, for which production has been discontinued and service/support is guaranteed only through December 31, 2025.

The VIDAS KUBE system replaces the discontinued VIDAS systems using the same consumable reagents and kits. FDA requires a contractual vehicle to meet all needs over the next five years, beginning with an initial purchase of instruments for each ORTS laboratory location in FY26, with multiple option years for additional units as needed.

SCOPE OF REQUIREMENT

Base Year Requirement:

• Quantity: Two (2) VIDAS KUBE systems per laboratory location

• Number of Locations: Seven (7) ORTS laboratories

• Total Base Year Units: 14 systems

• Configuration: Each system shall contain six (6) modules and one (1) PC

• Warranty: Minimum one-year warranty from date of installation

• Delivery Timeline: Within 60 days of award

Laboratory Locations:

1. Arkansas Human and Animal Food Lab, Jefferson, AR

2. Atlanta Human and Animal Food Lab, Atlanta, GA

3. Denver Human and Animal Food Lab, Denver, CO

4. Irvine Human and Animal Food Lab, Irvine, CA

5. New York Human and Animal Food Lab, Jamaica, NY

6. San Francisco Human and Animal Food Lab, Alameda, CA

7. Seattle Human and Animal Food Lab, Bothell, WA

KEY TECHNICAL REQUIREMENTS

Design and Flexibility:

• Modular, stackable benchtop design

• Support for up to six (6) modules operating simultaneously

• Integrated PC capable of controlling up to two (2) modules

• Processing capacity: 12-72 samples per cycle (food testing); up to 36 tests/hour/module

(clinical)

Technology and Performance:

• Enzyme-Linked Fluorescent Immunoassay (ELFA) technology

• Single-test concept with prefilled reagent strips and Solid Phase Receptacles (SPR)

• Compatible with minimum of 80 immunoassay tests including pathogen detection for

Salmonella spp. and Listeria spp.

Operational Requirements:

• Fully automated testing processes

• Intuitive software interface

• 21 CFR Part 11 compliant data traceability with audit trail functionality

• Cybersecurity protections

• Bi-directional Laboratory Information Systems (LIS) connectivity

• Quality control features including on-board verification, optical sample detection, and automated alerts

• Remote maintenance capability via VILINK® connectivity

Trade and Service Specifications:

• Newly manufactured units (not refurbished or demonstration units)

• 12-month parts and labor warranty from installation date

• All necessary supplies and accessories for installation and start-up

• FOB destination with inside delivery, set-up, and training

• On-site training for up to three (3) users per laboratory

• Installation by qualified field system engineer

• Training by qualified field application specialist

SECURITY REQUIREMENTS

Contractors must comply with the following security requirements:

8. IT applications must run in standard user context without elevated administrative privileges

9. Follow secure coding best practices per US-CERT and OWASP standards

10. Protect sensitive/proprietary information from unauthorized disclosure

11. Personnel must provide valid U.S. Real-ID with photo identification

12. Contractor personnel will be cleared as visitors upon arrival at each facility

INFORMATION REQUESTED

Interested parties are requested to provide the following information:

1. Company Information:

• Company name, address, DUNS number, CAGE code

• Business size and socioeconomic status (small business, woman-owned, veteran-owned, etc.)

• Point of contact with phone and email

2. Technical Capability:

• Confirmation that your company manufactures or distributes VIDAS KUBE systems or equivalent technology

• Detailed technical specifications demonstrating compliance with stated requirements

• Information on product lifecycle and availability over a 5-year period

• Plans for product updates or replacements during the contract period

• Compatibility with existing VIDAS consumable reagents and kits

3. Experience and Past Performance:

• Relevant contract experience with federal agencies, particularly FDA or other health/laboratory agencies

• Experience with multi-site installations and training

• References from similar projects (minimum 3)

4. Service and Support Capabilities:

• Installation and training capabilities across multiple geographic locations

• Warranty and post-warranty service options

• Remote maintenance and support capabilities

• Field service engineer and application specialist availability

5. Delivery and Logistics:

• Ability to meet 60-day delivery timeline

• Approach to coordinating installations across seven locations

• Shipping and handling procedures for sensitive laboratory equipment

6. Compliance and Security:

• Approach to meeting 21 CFR Part 11 requirements

• Cybersecurity measures and certifications

• Data protection protocols

• Compliance with federal security requirements

SUBMISSION INSTRUCTIONS

Responses to this RFI should be submitted electronically to Nina Montgomery;

nina.montgomery@fda.hhs.gov no later than March 10, 2026 at 10:00AM (EST). Please reference the RFI number in the subject line.

IMPORTANT NOTICES

13. This is NOT a solicitation:This RFI does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. It does not commit the Government to contract for any supply or service.

14. No reimbursement:The Government will not pay for information provided in response to this RFI or reimburse any costs incurred in preparing responses.

15. No evaluation:Responses will not be evaluated or scored. Information provided will be used for market research purposes only.

16. Proprietary information:If your response contains proprietary information, please clearly mark it as such. The Government will protect such information to the extent permitted by law.

17. Follow-on actions:Based on responses received, the Government may issue a formal solicitation. Companies responding to this RFI are not guaranteed consideration in any future solicitation.

POINTS OF CONTACT

Contracting Officer: Nina Montgomery; nina.montgomery@fda.hhs.gov mailto:nina.montgomery@fda.hhs.gov