Presolicitation Notice – Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument

PRESOLICITATION NOTICE Notice ID: NOI-FDA-133864 Subject: Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument, Installation, Operator Training, and Warranty Services SECTION 1 – IDENTIFICATION AND CLASSIFICATION CODES Contracting Office: U.S. Food and Drug Administration, Office of Acquisitions and Grants Services (OAGS), OC Acquisition Branch Contracting Officer: Maria Finan Address: 11601 Landsdown St. 13th floor, North Bethesda, MD 20852 CO Email: Linda.Finan@fda.hhs.gov NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing Product Service Code (PSC): 6630 – Chemical and Analytical Instruments SECTION 2 – SET-ASIDE STATUS A determination has been made by the Contracting Officer that competition to the maximum extent practicable is not feasible because only one source is reasonably available, consistent with RFO 12.201-1(c) and RFO 13.101(b). The intended award is single-source to Z-SPEC, INC., as the original equipment manufacturer (OEM). All responsible sources that believe they can fully satisfy this requirement are invited to submit a capability statement. See Section 5 for details. SECTION 3 – DESCRIPTION OF REQUIREMENT Per RFO 5.101(c)(4)(i), the following description is provided to allow prospective sources to make an informed business judgment about this requirement. Item 1 – Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument The U.S. Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), requires the purchase of one (1) Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument. The instrument will be used to perform rapid, non-destructive elemental analysis on regulated commodities to detect trace levels of toxic heavy metals, including elemental lead and elemental mercury. This acquisition is restricted to the Z-SPEC Z-max XRF Instrument, manufactured by Z-SPEC, Inc., in accordance with FAR 11.105, because it is the only commercially available instrument equipped with Doubly Curved Crystal (DCC) x-ray optics capable of monochromatic excitation required to achieve the Government's minimum limits of detection for elemental lead (≤ 0.03 ppm) and elemental mercury (≤ 0.05 ppm). A Sources Sought Notice was posted on SAM.gov on May 15, 2026; no vendors responded. The approved brand-name justification is on file. The instrument must meet or exceed the following minimum specifications: Doubly Curved Crystal (DCC) x-ray optics capable of monochromatic excitation Limit of Detection (LOD) for elemental lead: ≤ 0.03 ppm Limit of Detection (LOD) for elemental mercury: ≤ 0.05 ppm Minimum sample mass: 0.05 grams; Maximum sample mass: 3.0 grams Calibration range: from LOD to ≥ 10,000 ppm Benchtop or portable configuration; footprint not to exceed 30" W × 30" D × 30" H Power requirements: 110–120V New unit (not refurbished or demonstration model) Item 2 – Installation, Training, and Warranty The vendor shall provide, at no additional cost to the Government: Installation by a trained and certified field service engineer who shall perform the necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer's operational standards following installation. Calibration solutions and consumables used for the installation shall be included. Operator level training for 2 users at the delivery onsite location shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine regulatory analyses. The training shall include manuals and any consumables to be used during training. A minimum 12-month warranty for parts and labor commencing upon Government acceptance. Warranty coverage shall include all non-consumable items and parts, factory-certified replacement parts, engineer labor and travel costs. All warranty and repair work shall be performed by an OEM-trained engineer with: (1) access to OEM factory telephone support; (2) access to the most current OEM factory training for both hardware and software components; and (3) access to all current OEM factory parts. The OEM-trained service engineer shall not use salvaged parts from other instruments. All parts used in maintenance and repairs must be guaranteed, factory-tested, OEM quality parts. Item 3 – Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user with a field service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, and detailing the reason for the service call, a description of the work performed, the test instruments used, the name and contact information of the technician, and the on-site hours expended and parts replaced. The Contractor shall provide monthly reports to the FDA Project Officer and Contract Specialist, not later than the 5th business day following the end of each month, summarizing all maintenance and repair activities for the previous month. SECTION 4 – INTENDED SOURCE AND BASIS FOR NONCOMPETITIVE ACTION Pursuant to RFO 5.101(c)(4)(vii), the following identifies the intended source and explains why competition is not practicable for this requirement. Intended Contractor: Z-SPEC, Inc. 15 Tech Valley DR STE 110 East Greenbush, New York, 12061-4137, United States CAGE Code: 21BJ9 The basis for limiting this solicitation to a single source is that only one source is reasonably available, consistent with RFO 13.101(b) and the single-source standard at RFO 12.201-1(c). Z-SPEC, Inc. is the original equipment manufacturer (OEM) of the Z-max X-Ray Fluorescence (XRF) Instrument and the only source capable of meeting the Government's minimum need. Specifically: (a) The Z-max is the only commercially available XRF instrument equipped with Doubly Curved Crystal (DCC) x-ray optics capable of monochromatic excitation. This optical technology…