PreSolicitation_Notice_NOI-FDA-133864.docx

ALP: CDER-2026-133864

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 is proprietary to Z-SPEC, Inc. and is essential to achieving the Government's required limits of detection for elemental lead (≤ 0.03 ppm) and elemental mercury (≤ 0.05 ppm).

(b) Market research conducted March 2–20, 2026 evaluated three alternative instruments — the Spectro Xepos, Rigaku NEX CG II, and Malvern Panalytical Epsilon 4. None of these instruments are equipped with DCC x-ray optics or capable of monochromatic excitation, and therefore none can achieve the required limits of detection. Additionally, all three require a minimum sample mass of 3.0 grams, whereas the Z-SPEC Z-max is capable of analyzing samples as low as 0.05 grams — a critical capability given the range of regulated commodities tested by IRVLMP.

(c) A Sources Sought Notice was posted on SAM.gov on May 15, 2026; no vendors responded. Z-SPEC, Inc. is available from the manufacturer only; no authorized resellers or distributors exist.

A written brand-name justification has been prepared and approved in accordance with FAR 11.105, RFO 12.201-1(c), and RFO 13.101(b).

SECTION 5 – CONTRACT TYPE AND AWARD PROCEDURES

Per RFO 5.101(c)(4)(ii), the following describes the award procedures and anticipated award date for this action, which is valued above $25,000 but at or below the Simplified Acquisition Threshold (SAT).

Contract Type: Firm-Fixed-Price (FFP) Purchase Order Procedures: Simplified acquisition procedures per RFO 12.201-1 Anticipated Solicitation Issuance: July 21. 2026 Anticipated Award Date: On or before August 10, 2026 Documentation: Award will be documented in accordance with RFO 12.204

SECTION 6 – SOURCES SOUGHT / CAPABILITY STATEMENTS

Pursuant to RFO 5.101(c)(4)(vi), all responsible sources that believe they can fully satisfy this requirement are invited to submit a capability statement or expression of interest.

Response Deadline: July 14, 2026, 10:00 AM Eastern Time Submit to: Contracting Officer, Linda.Finan@fda.hhs.gov and Freshta.Javid@fda.hhs.gov .

Capability statements must address, at a minimum:

Demonstrated experience performing installation, commissioning, and qualification of Z-SPEC Z-max XRF instruments, or functionally equivalent OEM-proprietary XRF instruments utilizing Doubly Curved Crystal (DCC) x-ray optics, including evidence of access to required interface specifications and technical documentation.

Authorization status with respect to Z-SPEC Z-max instrument modification, servicing, and qualification documentation issuance.

Demonstrated capability to achieve limits of detection of ≤ 0.03 ppm for elemental lead and ≤ 0.05 ppm for elemental mercury using the offered instrument.

Business size under NAICS 334516 (or the applicable code confirmed by the CO).

Relevant prior contract performance: contract numbers, agency points of contact, dollar values, and period of performance.

Responses will be used solely to assess whether a competitive procurement is practicable. The Government will consider all capability statements received by the response deadline. A determination not to compete based on information received is solely within the discretion of the Government.

Capability statements submitted in response to this notice are not offers and cannot be accepted to form a binding contract. The Government is not obligated to issue a solicitation or award a contract as a result of this notice.

No phone calls will be accepted. All inquiries must be submitted in writing to the contracting officer.

SECTION 7 – QUALIFICATION REQUIREMENTS

Per RFO 5.101(c)(4)(viii), offerors are advised that award of a contract under this requirement is conditioned on the contractor's ability to demonstrate authorization from Z-SPEC, Inc. to perform installation, commissioning, and qualification of the Z-max XRF Instrument. Offerors lacking such authorization will not be considered responsible sources for this requirement.

Notice ID: NOI-FDA-131696 | Page 1 of 2