Food Safety Real-Time Polymerase Chain Reaction (PCR) System
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), Human Foods Program (HFP), Office of Laboratory Operations and Applied Science (OLOAS), is conducting market research for Food Safety Real-Time Polymerase Chain Reaction (PCR) Systems. This is a Sources Sought notice to identify potential providers and inform future acquisition strategies, including potential set-asides. Responses are due by April 6, 2026, at 1:00 PM Central Time.
Purpose & Scope
This market research aims to gather information on available "Made in America" and other PCR systems to determine if future requirements should be set aside for small businesses, opened to full and open competition, or procured via sole-source. The FDA is seeking multiple PCR systems for its facility in Jefferson, AR, under Product Service Code 6640 (Laboratory Equipment And Supplies).
Key Requirements
The FDA requires Electro-Mechanical Dynamic Load Frame Systems that are compatible with current validated Applied Biosystems 7500 Fast Real-Time PCR System assays. Key technical specifications include:
- Detection Capability: Minimum of six (6) distinct targets simultaneously per reaction.
- Optical System: At least 6 decoupled excitation/emission filter channels, supporting 21+ distinct filter combinations, with factory calibration for specific dyes (e.g., FAM, SYBR Green, Cy5). Must detect 1.5-fold target quantity differences and have a 10-log dynamic range.
- Thermal Block: 96-well, 0.1ml configuration, compatible with 0.1 mL, 0.2 mL, and 384-well formats. Operational temperature range of 4°C to 99.9°C with tight temperature variation.
- Connectivity & Data Management: Support for USB, Wi-Fi, LAN, and manufacturer's cloud platform for remote monitoring and secure data sharing.
- User Interface & Software: Minimum 8.5-inch touchscreen, pre-optimized protocol templates, multi-level user access, electronic audit trail, E-signature (21 CFR Part 11), and ALCOA+ data integrity features.
- Performance: Throughput run time for 96-well 0.2 mL block using fast chemistry protocols in under 30 minutes, designed for continuous uptime, and minimal routine maintenance.
- Computer System: If PC-attached, must meet specified processor, RAM, and OS requirements (e.g., Intel Core i5, 16 GB RAM, Windows 10).
- Acceptance Criteria: Detailed IQ/OQ/PQ requirements are specified.
Submission Details
Interested parties must submit responses via email to Howard Nesmith (howard.nesmith@fda.hhs.gov) by April 6, 2026, at 1:00 PM Central Time. Submissions should include:
- Proposed Product Information and Description.
- Capability Statement indicating if the product is "Made in America."
- Business Name, Unique Entity ID (SAM) Number, and full contact information.
- NAICS Small Business Program Representations (Small or Large).
- Country of Origin for proposed product(s) if not "Made in America." Informational pricing is encouraged but not mandatory.
Eligibility & Set-Aside
Responses are sought from:
- Providers of "Made in America" products (regardless of business size).
- Small Businesses under NAICS 334516 (Analytical Laboratory Instrument Manufacturing) with a 1,000-employee size standard, offering "Made in America" products.
- Providers of products made "Outside America" (regardless of business size). This notice is for market research only and does not obligate the government to award a contract.
Additional Notes
No proprietary, classified, confidential, or sensitive information should be included in responses. The government reserves the right to use non-proprietary technical information in future solicitations.