FDA-SSN24-120539.pdf

Sources Sought Notice

FDA-SSN24-120539

Luminex FLEXMAP 3D Instrument with xPONENT 4.3 Software or Equal

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing FLEXMAP 3D with xPONENT 4.3 Software.

The appropriate NAICS code for the acquisition is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size standards - 1,000 employees.

Background:

NCTR, Division of Microbiology requires a FLEXMAP 3D (FM3D) platform for use in approved protocol E0220101, E0744311, E075901 for the measurement of cytokines, chemokines, antibodies, and other secreted biomolecules. The FLEXMAP 3D (FM3D) is a flexible, flowcytometry based, analysis system for assays based on xMAP magnetic and non-magnetic beads. The instrument may distinguish up to 500 unique, preset bead spectral addresses within a single sample.

This requirement is as Brand Name or Equal configuration:

- Luminex FLEXMAP 3D instrument with xPONENT 4.3 Software, part # 40-014, 1 - Each

Minimum Technical Requirements:

A. FLEXMAP 3D instrument shall include-

1. User-friendly plate setup features allowing for speed and efficiency.

2. Various publication-quality presentation styles.

3. Several optional report formats; report information can be easily exported as Excel or PDF for data presentation.

4. Ability to analyze data from up to 6 plates for a single report.

5. Automatic determination of best curve fitting model and calculation of min/max detectable concentrations.

6. Qualitative data analysis available as well as reference/normalization capabilities.

7. QC tools to quickly gauge goodness of fit.

8. Data is flagged by color to quickly determine whether samples are below, above, or within quantifiable range; rapid data scan to ensure data hygiene.

9. Separate QC report which will automatically determine which samples need to be re-analyzed based on user defined parameters (e.g. low bead number, high CV).

10. Powerful user control to define acceptable ranges, thresholds, slope, CV, correlation coefficient, and other parameters.

11. Easily compare standard curve performance against previous experiments to confirm statistical similarity/parallelism.

12. The ability to detect up to 500 analytes

•96-well plate in ~20 min 384-well plate in ~75 min •Flow-based with lasers •≥4.5 logs dynamic range

13. Equipment-

• FM3D Unit (includes Analyzer, XYP plate handler)

• PC bearing xPONENT 4.3 and Windows 10

• Dimensions including PC, 110x62x63cm, Weight 77.1kg (170lbs).

14. Ancillary Equipment-

• Keyboard and mouse.

• Power cables.

• USB Communication cables.

• Off plate reagent area.

• Automated Maintenance Plate (AMP).

• 96 & 384 well heater block.

• 3 sample probes.

• Sample probe alignment kit.

• Sheath fluid intake line.

• Waste fluid out take line.

• Empty cubitainer for waste.

• Monitor arm.

• Barcode reader (optional)

15. Consumables

16. Calibration Kit

17. A minimum of 12-month manufacturer's warranty.

18. Onsite installation and training

B. One (1) option year of Preventative Maintenance and Repair Services shall include:

1. The FLEXMAP 3D Instrument.

2. At least one (1) preventative maintenance visit per year.

3. Emergency repair of the system that requires a technician to perform the repair onsite shall be completed within 48 hours.

4. Emergency repair that can be handled by phone/email response time shall be 24 hours.

5. Performance by formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

6. Preventive maintenance and repair service inclusive of shipping, labor, travel, replacement parts, subassemblies, components, or modules necessary for repairs, etc.

7. Unlimited technical support (phone and email) technical support Mondays – Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time and shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.).

8. Access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates.

Service Records and Reports:

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Anticipated Delivery:

FOB Point Destination. Shipping, handling, in-side delivery, installation and on-site training shall be not later than 60 calendar days after receipt of contract.

Place of Delivery/Performance:

U. S. FDA – National Center for Toxicological Research 3900 NCTR Road Bldg. 60/113 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, SAM UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures, and other information.

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and

SINs that are applicable to this potential requirement are also requested.

5. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

6. If a large business, provide if subcontracting opportunities exist for small business concerns.

7. Standard commercial warranty.

8. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

9. Though this is not a request for quote, informational pricing is being requested.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before June 21, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN24‐120539.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern.