SPECIAL NOTICE
66 -- Notice of Intent to Sole Source EndoSafe NexGen PTS
- Notice Date
- 6/29/2016
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH16T0292
- Archive Date
- 7/28/2016
- Point of Contact
- James Cheng, Phone: 3016191012
- E-Mail Address
-
james.cheng1.civ@mail.mil
(james.cheng1.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Walter Reed Army Institute Of Research (WRAIR) to procure an EndoSafe NexGen PTS without competition as prescribed in FAR 13.106-1(b)(1)(i). Specifically, the Government will procure this device manufactured by Charles River Laboratories. Charles River Laboratories is the sole source provider of this product with no certified resellers. The Charles River EndoSafe nexgen-PTS System is the only product available that is a portable, rapid, point-of-use test system that utilizes existing FDA-licensed LAL reagents in a test cartridge with a hand-held spectrophotometer and is the only automated LAL system that does not require an external computer for data acquisition and analysis. The EndoSafe nexgen-PTS is the only product that mimics licensed LAL kinetic chromogenic methodology by measuring color intensity directly related to the endotoxin concentration in a sample. Each cartridge contains precise amounts of licensed LAL reagent, chromogenic substrate, and control standard endotoxin (CSE). SEVI uses proprietary microfluidic cartridges that are only compatible with the EndoSafe nexgen-PTS. The EndoSafe nexgen-PTS device is the only product that is FDA approved, portable, sensitive to 0.005 EU/ml, and does not require a computer for the interpretation of assay data. IQ/OQ/PQ qualification is available and re-validation of the instrument is cost-effective. Considerable effort into the development of SOPs, validation of SOPs, and the marketing of SEVI's ability to perform the endotoxin tests expeditiously with the EndoSafe-PTS are already in place. In the event that another LAL device is purchased in lieu of the EndoSafe nexgen-PTS reader, SEVI will lose the ability to perform this assay per the previously developed SOPs, with all of the proprietary microfluidic device consumables being wasted. The North American Industry Classification System (NAICS) for this requirement is 334516 and FSC 6640. Proposed solicitation number: W81XWH-16-T-0292. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as brand name only. All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@mail.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 4:00 PM ET, 13 June 2016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH16T0292/listing.html)
- Place of Performance
- Address: WRAIR, 503 Robert Grant Ave, Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04166791-W 20160701/160629235619-d82020c59eb0b5bf6810f25acca87e40 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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