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
Submission Deadline
Apr 3, 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 combined synopsis/solicitation (RFQ) aims to acquire an instrument that enhances responsiveness by reducing incubation time and providing faster sterility results. The competition is Full and Open. Quotes are due April 3, 2026, by 1:00 P.M. Central Time.
Scope of Work
The required instrument must:
- Utilize ATP-bioluminescence technology for microbial detection.
- Be compatible with USP <71> compendial media (Soybean-Casein Digest broth and Fluid Thioglycollate broth) and support both filterable and non-filterable pharmaceutical products.
- Have a minimum testing capacity of 28 tests per hour.
- Feature automated reagent addition and result reading.
- Include software compliant with 21 CFR Part 11.
- Be a benchtop model, no larger than 24" x 24" x 24" (WxDxH), and 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, components, instruments, computers, and software.
- On-site operator training for two users and a minimum one-year warranty from FDA acceptance are required.
- Offerors must submit an Accessibility Conformance Report (ACR) or HHS Section 508 Accessibility Conformance Checklist.
Contract & Timeline
- Contract Type: Commercial Item - Firm Fixed Price
- NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing (Small Business Size Standard: 1,000 employees)
- Set-Aside: Full and Open Competition
- Response Due: April 3, 2026, by 1:00 P.M. Central Time
- Published: March 24, 2026
- Offer Acceptance Period: Quotes must be firm through September 30, 2026.
Submission & Evaluation
- Submission Method: Offers must be submitted via email only to warren.dutter@fda.hhs.gov.
- Evaluation Criteria: Award will be made to the Lowest Priced Technically Acceptable (LPTA) responsible quoter/offeror. Quotes will be evaluated on their ability to meet the 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.
- Note: Electronic documents must not contain macros; submissions with macros will be considered non-responsive.
Point of Contact
- Primary: Warren Dutter, Contracting Officer (warren.dutter@fda.hhs.gov, 301-796-2486)
People
Points of Contact
Warren DutterPRIMARY
Files
Files
Versions
Version 1Viewing
Combined Synopsis/Solicitation
Posted: Mar 24, 2026