Rapid Sterility Instrument
SOL #: 75F40126Q132933Combined Synopsis/Solicitation
Overview
Buyer
Health And Human Services
Food And Drug Administration
FDA OFFICE OF ACQ GRANT SVCS
Rockville, MD, 20852, United States
Place of Performance
Irvine, CA
NAICS
Analytical Laboratory Instrument Manufacturing (334516)
PSC
Laboratory Equipment And Supplies (6640)
Set Aside
No set aside specified
Original Source
Timeline
1
Posted
Mar 24, 2026
2
Last Updated
Apr 3, 2026
3
Submission Deadline
Apr 9, 2026, 6:00 PM
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 Food and Drug Administration (FDA) is soliciting quotes for a Rapid Sterility Instrument for its Irvine Medical Products Laboratory (IRVLMP) in Irvine, CA. This instrument will enhance responsiveness by providing faster sterility results compared to conventional methods. This is a Combined Synopsis/Solicitation for commercial items, issued as a Request for Quote (RFQ) under FAR Part 12. Quotes are due by April 9, 2026, at 1:00 P.M. ET.
Scope of Work
The FDA requires a Rapid Sterility Instrument utilizing ATP-bioluminescence technology for microbial detection. Key requirements include:
- Compatibility with USP <71> compendial media (Soybean-Casein Digest broth and Fluid Thioglycollate broth) and support for both filterable and non-filterable pharmaceutical products.
- Minimum testing capacity of 28 tests per hour.
- Automated reagent addition and result reading.
- Software compliant with 21 CFR Part 11.
- Benchtop model, not exceeding 24" x 24" x 24" (WxDxH), compatible with standard US electrical outlets (100-120V, 50/60 Hz).
- All components must be newly manufactured.
- The contractor must provide a turn-key solution, including all necessary hardware, instruments, computers, and software.
- On-site operator training for two users.
- A minimum one-year warranty from FDA acceptance.
- Offerors must submit an Accessibility Conformance Report (ACR) or HHS Section 508 Accessibility Conformance Checklist.
Contract Details
- Contract Type: Firm Fixed-Price for Commercial Items.
- Set-Aside: Full and Open Competition.
- NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing (Small Business Size Standard: 1,000 employees).
- Place of Performance: Irvine, CA 92612, United States.
Submission & Evaluation
- Submission Method: Quotes must be submitted via email only to warren.dutter@fda.hhs.gov. Electronic documents must not contain macros.
- Deadline: April 9, 2026, by 1:00 P.M. ET.
- Evaluation Criteria: Award will be made to the lowest priced technically acceptable responsible quoter/offeror. Quotes will be evaluated on their ability to meet requirements, with the lowest priced quote evaluated first.
- Technical Information: Quoters must provide sufficient technical information to demonstrate compliance with or exceeding minimum technical requirements.
- Offer Acceptance Period: Quotes must remain firm through September 30, 2026.
Point of Contact
- Contracting Officer: Warren Dutter (warren.dutter@fda.hhs.gov, 301-796-2486).
People
Points of Contact
Warren DutterPRIMARY
Files
Files
Versions
Version 2Viewing
Combined Synopsis/Solicitation
Posted: Apr 3, 2026
Version 1
Combined Synopsis/Solicitation
Posted: Mar 24, 2026