FDA shear flow instrument system

18 This is a combined synopsis-solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The solicitation number 75F40126Q133903 is issued as a Request for Quote (RFQ) for a BioFlux 200+ or equal flexible shear flow system for microscopy. This acquisition is set aside for small business concerns under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Equipment Manufacturing; with a Small Business Size Standard of 1,000 employees. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. Offerors are responsible for submitting, by e-mail ONLY, quotes and supporting documents to Tim Walbert, timothy.walbert@fda.hhs.gov NLT 2:00 pm CDT on June 16, 2026. Schedule of Supplies or Services and Prices/Costs. Line Item 01 BioFlux 200+ or equal flexible shear flow system, to include delivery F.o.b. Destination and meeting the minimum technical requirements set forth below Quantity: 1 Unit: Each Price: ____________________ Country of Manufacture or Origin: ______________________________ GSA Contract Number (if applicable): ____________________________ Background and Requirement The U.S. Food and Drug Administration (FDA), Laboratory of Cellular Hematology (LCH), requires FDA CBER requires a BioFlux 200+ or equal flexible shear flow system to evaluate human platelets and red blood cells in their physiological environment to avoid animal use. This system is designed for physiological shear flow by effectively mimicking in vivo conditions and revealing the true biology of cells. This allows easier study of how cells behave under flow conditions—without the complexity of custom-built setups such as expensive organoid chips, etc. The required system also eliminates some of the cumbersome in vivo experiments and reduces animal usage, which is a high priority for the FDA. The primary research responsibility of the LCH is to perform functional characterization of cellular blood components such as platelets and red blood cells that have undergone experimental treatments. This work involves applying various treatments to the cells and performing in vitro assays to evaluate any functional impediments caused by the treatments. LCH has several ongoing projects that will benefit from the usage of this system, including hematology (platelet aggression, thrombus formation), endothelial cell studies (permeability, inflammation, drug response), and vascular biology (cell adhesion, atherosclerosis modeling). Critical to this acquisition is the use of “brand name or equal” when describing the instrument as a whole and/or specific components and their salient performance characteristics as it relates to a -- 1 of 12 -- 19 scientific need. In this case, “brand name or equal” applies to a flexible shear flow instrument system specifically designed to mimic in vivo conditions. Where an offeror submits an equal instrument for consideration, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements. Salient characteristics that a BioFlux 200+ or equal flexible shear flow system shall meet are as follows: *A stand-alone shear flow system, new and not refurbished; *Must be compatible and seamlessly integrate with existing Nikon Eclipse Model TE200-U inverted microscope; *Shall be a comprehensive and closed system capable of addressing multiple types of cell-related scientific questions, especially with human platelets and red blood cells; *Shall provide uniform and reproducible pressures for the cells to move in microfluidic channels; *Capable of reproducible and repeatable shear flow rates to be programmed between 0-200 dynes/cm2; *Capable of single and bi-directional flow; *Shall pulsatile flow to simulate heartbeat up to 120/bps; *Environmental control at the sample level with dual gas input options; *Throughput of up to 24 individual experiments per plate depending on configuration; *24, 48, and 96-well plate configurations; *Two (2) shear flow input experiments for gradient based image analysis from dual inputs; *Include a computer workstation to run operating software; *Include a minimum one-year full manufacturer’s warranty. Delivery – FOB Destination U.S. FDA Center for Biologics Evaluation and Research (CBER) 10903 New Hampshire Avenue, Bldg. 52/72, Room 5320 Silver Spring, MD 20993-0002 Deliveries, installations, or services shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows: New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Independence Day Contract Type Firm Fixed-Price Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Contract Clauses: This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract- policies-regulations/hhsar/index.html -- 2 of 12 -- 20 FAR Clauses Required: 52.212-4 Contract Terms and Conditions-Commercial Items (Deviation SEP 2025) Applicable: 52.203-17 Contractor Employee Whistleblower Rights (Nov 2023) 52.204-13 System for Award Management Maintenance (DEVIATION) (RFO AUG 2025) 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Susp…