FDA shear flow instrument system
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Laboratory of Cellular Hematology (LCH), is soliciting quotes for a shear flow instrument system designed to mimic in vivo conditions for evaluating human platelets and red blood cells. This acquisition is a Total Small Business Set-Aside under NAICS Code 334516. Quotes are due June 16, 2026, by 2:00 pm CDT.
Purpose & Scope
The FDA requires a BioFlux 200+ or equal flexible shear flow system for microscopy. This system will enable the LCH to evaluate human platelets and red blood cells in physiological conditions, aiming to reduce reliance on animal testing and cumbersome in vivo experiments.
Key Requirements / Deliverables
- One (1) BioFlux 200+ or equal flexible shear flow system, new and not refurbished.
- Must be compatible with Nikon Eclipse Model TE200-U inverted microscope.
- Comprehensive, closed system for cell-related scientific questions.
- Capable of uniform and reproducible pressures with programmable shear flow rates between 0-200 dynes/cm2.
- Features single/bi-directional flow and pulsatile flow up to 120/bps.
- Includes environmental control at the sample level with dual gas input options.
- Supports throughput of up to 24 individual experiments per plate (24, 48, and 96-well configurations).
- Two (2) shear flow input experiments for gradient-based image analysis.
- Includes a computer workstation with operating software.
- Minimum one-year full manufacturer's warranty.
Contract Details
- Contract Type: Firm Fixed-Price.
- Period of Performance: Offer prices must be held firm through September 30, 2026.
- Set-Aside: Total Small Business (FAR 19.5).
- Product Service Code: 6640 (Laboratory Equipment And Supplies).
Submission & Evaluation
- Submission Deadline: June 16, 2026, by 2:00 pm CDT.
- Submission Method: Quotes must be submitted via e-mail ONLY to Tim Walbert (timothy.walbert@fda.hhs.gov).
- Evaluation Factors: Award will be made to the responsible Offeror whose offer is most advantageous to the Government, based on Technical Acceptability and Price. The lowest priced technically acceptable offer will be selected.
- Technical Acceptability: Determined by review of descriptive material, literature, and brochures demonstrating capabilities against minimum technical requirements.
Eligibility / Set-Aside
This opportunity is set aside for small business concerns under NAICS Code 334516 (Analytical Laboratory Equipment Manufacturing) with a 1,000-employee size standard.
Additional Notes
Offerors must be registered and active in SAM.gov by the quote submission deadline. Electronic documents must not contain macros. The solicitation incorporates FAR and HHSAR clauses by reference.