Logos Biosystems Luna FX7 Automated Cell Counter
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/17/2023
Procurement Summary
Luna FX7 Automated Cell Counter, CAT# L70001 Manufactured by Logos Biosystems in South Korea The National Institute of Allergy and Infectious Diseases (NIAID)’s Division of Intramural Research (DIR), Center for Human Immunology (CHI), develops and applies systems biology approaches which combines computation, modeling, and experiments to study the immune system at the organismal, cellular, and molecular levels. The CHI is a translational operation that will serve as a hub for facilitating the interaction of various immunologically oriented NIH investigators with an interest in translational studies while having access to cutting edge advanced technologies. The center provides technological resources which are often unavailable to individual laboratories due to costs, complexity, novelty, technological understanding, and expertise. Technology platforms include but not limited to, transcriptomics, single cell technologies such as CITE-seq, high parameter cytometry, and serum proteomics. The CHI is requesting an additional Logos Biosystems brand Luna FX7 Automated Cell Counter, it is the only know cell counter that meet the following requirements: 1. Automated cell counter system that can evaluate human samples and accurately determine the number of cells. 2. Cell counting system must be high-throughput and can evaluate 8 human subject samples simultaneously, without the concern of cross contamination. 3. Cell counting system must be accurate within 1.5% cell volume for samples greater than 5 microliters. 4. Cell counting system must have quality control software that validate the results of the cell count processed. Software must be compatible with (our current cell counter software) Countwire software and in compliance with 21 CFR Part 11.
Waiver Rationale Summary
Additional action(s) taken to find a domestically manufactured item: Brand Name or Equal combined synopsis and solicitation (Request for Quotes) was posted on SAM.gov with solicitation number; RFQ-NIAID-23-2176128 on SAM.gov from 7/14/2023 to 07/24/2023 with brand name or equal salient characteristics, and compatibility requirements. This solicitation received three (3) foreign offers for the Luna FX7 Automated Cell Counter, manufactured in South Korea. Conclusion: Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2176128 posted on SAM.gov, no domestic products that meet the requirements were available. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. Three vendors responded to the solicitation (Request for Quotes), which was posted as full and open competition with a brand name or equal requirement, all three quotes were for the Luna FX7 Automated Cell Counter that is manufactured by Logos Biosystems, as requested, no domestic offers were received. The feasibility of foregoing the requirement or providing a United States-manufactured substitute has been considered, and no substitutes were found. Authority is requested to acquire the above-described Luna FX7 Automated Cell Counter, manufactured by Logos Biosystems in South Korea. Based on the findings detailed above, the Luna FX7 Automated Cell Counter, manufactured by Logos Biosystems are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that there are no domestic items available. There were no other instruments that could be identified in the commercial marketplace through market research as being manufactured in the United States that meet the brand. There were no other instruments that could be identified in the commercial marketplace through market research as being manufactured in the United States that meet the brand name or equal requirements. No domestic instruments could be identified through market research.
Yes
No
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/08/2023
N/A
RFQ-NIAID-23-2176128
Post-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH