Post-Award Public Notice

Posted Pursuant to 41 U.S.C. § 2304(f)(5) and RFO FAR Subpart 6.3 / FAR 6.305

Notice Type: Award Notice — Justification for Other Than Full and Open Competition

Date Posted: 08/21/2026

Contract Award Date: 08/21/2026

SECTION 1 — CONTRACT INFORMATION

Field Information

Agency U.S. Department of Health and Human Services (HHS)

Contracting Activity U.S. Food and Drug Administration (FDA), OƯice of Acquisitions and Grants Services (OAGS)

Contract Number 75F40126P00227

Contract Type Firm-Fixed-Price (FFP) Purchase Order

Contractor Name Z-Spec, Inc.

Contractor Address 15 Tech Valley Drive, Suite 110 East Greenbush, NY 12061

Contractor UEI SAM T3BAMJU1A835

Total Contract Value $ 123,075.00

Period of Performance 09/14/2026-09/13/2027

Place of Performance / Delivery U.S. Food and Drug Administration, College Park, MD

PSC Code 6640 — Laboratory Equipment and Supplies

NAICS Code 334516 — Analytical Laboratory Instrument Manufacturing

Small Business Size Standard 1,000 Employees

Field Information

Acquisition Procedure FAR Part 12 — Commercial Products and Commercial Services (RFO)

SECTION 2 — STATUTORY AUTHORITY FOR OTHER THAN FULL AND OPEN

COMPETITION

This contract was awarded without full and open competition pursuant to the authority of:

41 U.S.C. § 3304(a)(1) — Only one responsible source and no other supplies or services will satisfy agency requirements

RFO FAR 6.103-1 (formerly FAR 6.302-1) — Only one responsible source

SECTION 3 — DESCRIPTION OF SUPPLIES ACQUIRED

The FDA awarded a sole source, firm-fixed-price purchase order to Z-Spec, Inc. for the acquisition of the following brand-name commercial instruments:

- Z-Spec, Inc. Part number (106-01) Z-max Analyzer

- Z-Spec, Inc. Part number (102-02) E-max PLUS Analyzer

- Accessories, including sample cups, sample prep kit, transporting case, food/plant standards kit.

The instruments meet the following technical requirements:

1) System:

Detection Method: energy dispersive XRF

Optics: Doubly Curved Crystal (DCC) optics

Excitation: 17 keV excitation beam or greater

Power: compatible with standard U.S. 120V 60 Hz power Portability:

Field-portable design (<10 kg) combined with high analytical sensitivity, enabling both laboratory and on-site testing

2) Sample Preparation

Samples will be provided as dried powders, and purchase should include sample holders and/cup, along with XRF transparent film to hold powdered sample.

3) Performance Specifications - Required Limits of Detection Must meet ultra-low limits of detection for toxic elements (e.g., As, Cd, Hg, Pb, Tl) required for FDA regulatory and research applications.

Element LOD required (ug/g) As 0.03 Cd 0.04 Hg 0.06 Pb 0.06 Tl 0.06

4) Software and Data Management

Fundamental Parameters data model

Data Output: Integrated hardware/software architecture designed specifically for food safety and contaminant analysis workflows and data should be available for export in standard .txt or .csv formats

Connectivity: Ethernet, USB ports

The OƯice of Chemistry and Toxicology, Division of Bioanalytical Chemistry, Chemical Contaminants Branch requires the purchase of two portable Mono-Chromatic High Definition X-ray fluorescence spectrometers (mHD-XRF systems): the Z-max Analyzer and the E-max PLUS Analyzer. In support of the FDA's public health mission, these systems will support rapid analytical testing of foods, dietary supplements, cosmetics, and spices for toxic elements including arsenic (As), cadmium (Cd), mercury (Hg) and lead (Pb) detection.

The analytical capabilities may be extended to include additional elements as needed.

SECTION 4 — RATIONALE FOR OTHER THAN FULL AND OPEN COMPETITION

A. Unique and Proprietary Technology

The Z-max and E-max PLUS Analyzers are proprietary instruments exclusively designed, developed, and manufactured by Z-Spec, Inc. These instruments employ patented optical and detection architectures that are unique to Z-Spec, Inc. and are protected by intellectual property rights. These technologies are not available from any other manufacturer or source.

B. No Technically Equivalent Substitute

Market research conducted by the FDA prior to award confirmed that no other commercially available XRF or elemental analysis instrument provides equivalent analytical sensitivity, detection limits, and measurement methodology required to meet the Government's specific technical requirements. Conventional energy-dispersive XRF (EDXRF) instruments available from other manufacturers do not achieve the required detection performance levels.

C. Only One Responsible Source

Z-Spec, Inc. is the only responsible source capable of providing the Z-max and E-max PLUS Analyzers. No other vendor manufactures or supplies instruments of equivalent capability that would satisfy the Government's minimum needs in terms of the technical requirements.

SECTION 5 — EFFORTS TO OBTAIN COMPETITION

In accordance with RFO FAR 6.103-1 and prior to award, the FDA posted a Notice Of Intent For A Sole Source Award on SAM.gov on 07/29/2026, providing all interested parties 15 calendar days to respond with capability statements or oƯers demonstrating the ability to meet the Government's requirements.

No responses were received demonstrating the capability to meet the Government's requirements.

Accordingly, the FDA determined that Z-Spec, Inc. is the only responsible source capable of satisfying the Government's requirements and proceeded with a sole source award.

SECTION 6 — PRICE REASONABLENESS

The Contracting OƯicer determined that the price of $ 123,075.00 is fair and reasonable based on comparison with the invoices provided by Z-Spec, Inc. of the same instruments sold to other commercial entities.

SECTION 7 — MARKET RESEARCH

Market research was conducted by the FDA in accordance with RFO FAR Part 10. The market research confirmed that no other commercially available instrument meets the Government's specific technical requirements.

SECTION 8 — ACTIONS TO FOSTER FUTURE COMPETITION

The FDA will take the following actions to foster competition for future requirements:

1. Continue to monitor the commercial marketplace for the emergence of alternative XRF instruments capable of meeting FDA's technical requirements;

2. Engage in market outreach and industry days as appropriate; and

3. Evaluate whether future requirements can be structured to promote competition at the time of any follow-on procurement.

SECTION 9 — CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Min Jie Zeng

Contracting OƯicer

U.S. Food and Drug Administration

OƯice of Acquisitions and Grants Services

08/21/2026