SOLICITATION NOTICE
65 -- Blood deformability Meter
- Notice Date
- 9/14/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Req1062497
- Archive Date
- 10/1/2009
- Point of Contact
- Tiffany K McGant, Phone: 3018272888
- E-Mail Address
-
Tiffany.McGant@fda.hhs.gov
(Tiffany.McGant@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- REQ1062497 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 334516, identified as REQ1062497, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Background:A red blood cell deformability analyzer is needed to provide rapid and accurate measurements of red blood cell deformability to support blood damage analysis for the Blood Damage Assessment Laboratory in CDRH/OSEL. This instrument is essential to our research, because we regularly conduct experiments with human and animal blood and it is necessary to know the hematological parameters for each test. Blood cell fragility is a serious issue for a variety of medical devices. This instrument is needed to quantify cell properties that affect blood fragility during the safety evaluation for the universe of medical devices. This will include collaboration with NIST. Consequences of not funding: Without this system, OSEL is hampered in its ability to asses blood damaging performance of a wide array of cardiovascular products. Performance Specification Requirements: The red blood cell deformability analyzer must conform to the following key specifications: 1. Species: The instrument must be capable of testing with human blood, and it is possible to operate it with animal blood. 2. Blood sample volume should be less than 10 microliters to accommodate small sample volumes. 3. Measuring parameters: The instrument must be capable of reporting red blood cell elongation as a function of multiple shear stresses. 4. Automation: The instrument must automatically perform image-processing during the analysis to relate red blood cell elongation to shear stress, and provide a graphical plot of the results. 5. Measurement cycle time: no longer than 1 minute per sample. 6. Disposable plastic test kits are required to prevent washing the instrument between samples and possible contamination with blood. 7. The instrument must have been validated against a conventional laser-diffractometry system. 8. Computer interface: The instrument must have a computer interface to export elongation results to Microsoft Excel for data analysis and post-processing. 9. Ease of maintenance: does not require time-consuming daily or weekly system maintenance. 10. Power requirements: 120 V, 50/60 Hz for use in the United States. 11. The instrument must be a stand-alone device and not require any other equipment besides a computer that will be supplied by the purchaser. Deliverables: BY NOVEMBER 9, 2009
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/Req1062497/listing.html)
- Place of Performance
- Address: Multiple Destinations, United States
- Record
- SN01953641-W 20090916/090915000741-7f5c959bdeac016e8aa437fb6d961042 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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