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FBO DAILY ISSUE OF SEPTEMBER 16, 2005 FBO #1390
SOLICITATION NOTICE

66 -- SmartCycler System

Notice Date

9/14/2005
 

Notice Type

Solicitation Notice
 

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, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

Reference-Number-RQN1002444
 

Response Due

9/19/2005
 

Archive Date

9/19/2005
 

Description

The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Cepheid Inc., 904 Caribbean Drive, Synnyvale, CA. Cepheid, Inc. is the sole developer and manufacturer of the SmartCycler System and its associated accessories. There are no known substitutes and there are no similar instruments. The unique features to the SmartCycler System are as follows: 1. The thermal cycler must be capable of rapid, real-time PCR experimental analysis; the thermal cycler must be capable of performing sample amplification and analysis in as few as 20 to 30 minutes. 2. The thermal cycler must have individually programmable sample processing sites, with the capability to simultaneously run assays that utilize different thermal cycling protocols and/or fluorescent reporting dye combinations. 3. The instrument must be capable of accommodating multiple users simultaneously ? allowing operators to utilize any unused sample processing sites to start new runs while the instrument is already running the assays of other users. 4. The real-time thermal cycler must be expandable, capable of being configured with as few as 16 or as many as 96-sample reaction sites, and yet maintain the ability to independently program each sample reaction site. 5. Each of the individual reaction sites must have its own independent thermal cycling and optical control system, with the ability to accurately record all thermal and spectral (fluorescent) measurements for each sample reaction site. 6. The real-time thermal cycler must utilize reaction tubes that are virtually unbreakable with normal use. 7. The instrument must not require the use of a normalization dye such as Rox or Fluorescein. 8. The instrument must be factory calibrated to optimally detect 4 distinct fluorescent dyes simultaneously (FAM, Cy3, TET, Alexa 532, Texas Red, Cy5, or Alexa 647) and must also be calibrated for use with SYBR Green. 9. The instrument must be capable of melt-curve anlysis when SYBR green, Molecular Beacon, or Scorpion chemistries are employed. 10. The Instrument software must be capable of performing and illustrating 2nd derivative Ct analysis. 11. The Instrument software must be capable of automatically advancing to the next cycling stage after a Ct crossing in a user-designated optical channel. 12. The instrument must have the capability to be easily transported with an optional ruggedized hardened carrying case. NO REQUEST FOR QUOTE (RFQ) IS AVAILABLE. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the fifth (5th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to Fred.Ettehadieh@fda.gov. No phone calls will be accepted. An award will be made in five (5) calendar days from the date of this notice. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.
 

Place of Performance

Address: FDA/CFSAN 6502 S. ARCHER ROAD, BEDFORD IL

Zip Code: 60501

Country: USA
 

Record

SN00894747-W 20050916/050914211752 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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