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

Background
The U.S. Food and Drug Administration (FDA), specifically the Office of Acquisitions and Grants Services (OAGS), is seeking to procure a Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument for the Irvine Medical Products Laboratory (IRVLMP). This instrument is essential for performing rapid, non-destructive elemental analysis on regulated commodities to detect trace levels of toxic heavy metals, including elemental lead and mercury. The contract is being awarded to Z-SPEC, Inc., the original equipment manufacturer (OEM) of the Z-max XRF Instrument, as it is the only source capable of meeting the FDA's stringent requirements.

Work Details
The contract includes the purchase of one (1) Z-SPEC Z-max X-Ray Fluorescence (XRF) Instrument with specific requirements:
- Must be equipped with 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.
- Configuration must be benchtop or portable with a footprint not exceeding 30" W × 30" D × 30" H.
- Power requirements: 110–120V.
- The unit must be new, not refurbished or a demonstration model.

Additionally, the vendor must provide installation by a certified engineer, operator training for two users at the delivery site, and a minimum 12-month warranty covering parts and labor upon government acceptance.

Place of Performance
U.S. Food and Drug Administration, Irvine Medical Products Laboratory, North Bethesda, MD.

Bidder Requirements
Bidders must 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.