Mettler Toledo HX204 Halogen Moisture Analyzer (or equivalent)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Office of the Chief Scientist (OCS), San Juan Medical Products Laboratory (SJNLMP) is seeking a Mettler Toledo HX204 Halogen Moisture Analyzer, or equivalent, through a Combined Synopsis/Solicitation (RFQ). This requirement includes delivery, installation, qualification, and training for a new instrument to replace a manual moisture analysis method. Quotes are due April 15, 2026.
Scope of Work
The FDA requires a high-performance halogen moisture analyzer capable of real-time monitoring, reporting, user management, and method storage. The instrument must meet specific technical specifications including a readability of at least 0.001 %MC (0.1mg) and a maximum capacity of at least 200g. It must also comply with cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11 standards. The requirement includes an Instrument Controller Software with licensing, data collection, reporting, and firmware.
Deliverables & Services
- Instrument: Newly manufactured Mettler Toledo HX204 Halogen Moisture Analyzer or equivalent.
- Delivery & Installation: Within 90 days of contract award by factory-certified personnel at the San Juan Medical Products Laboratory.
- Training: On-site operator training for 3-5 users.
- Warranty: Minimum one (1) year from FDA acceptance, including on-site training.
Contract Details
- Contract Type: Firm Fixed Price for a Commercial Product.
- NAICS Code: 334516 Analytical Laboratory Instrument Manufacturing (Size Standard: 1,000 employees).
- Set-Aside: Full and open competition.
- Place of Performance: San Juan Medical Products Laboratory, San Juan, PR.
- Buy American: Subject to the Buy American Statute.
Submission & Evaluation
- Submission Method: Quotes must be emailed to Suzanne Martella (suzanne.martella@fda.hhs.gov).
- Deadline: April 15, 2026, at 1:30 PM Central Time.
- Evaluation Criteria: Award will be made to the lowest priced technically acceptable responsible quoter.
- Technical Information: Quoters must provide sufficient technical data, descriptive material, literature, and brochures to demonstrate compliance. For "equal" products, a narrative explaining how salient characteristics are met is required.
- Accessibility: Section 508 compliance is mandatory, requiring an Accessibility Conformance Report (ACR) or equivalent.
- Other Requirements: Include Unique Entity ID (UEI) number. Prices must be firm through September 30, 2026.
Contact Information
- Primary Contact: Suzanne Martella, suzanne.martella@fda.hhs.gov, 301-796-2383.