SOLICITATION NOTICE
B -- PTS Detection System With Endoscan V Software (Brand Name Or Equal)
- Notice Date
- 7/9/2009
- 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
- FDA1060040
- Archive Date
- 9/30/2009
- Point of Contact
- Michelle Street, Phone: 3018277155, Gina Jackson, Phone: 301-827-7181
- E-Mail Address
-
Michelle.Street@fda.hhs.gov, gina.jackson@fda.hhs.gov
(Michelle.Street@fda.hhs.gov, gina.jackson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Food and Drug Administration is in need of support for analytical demands requiring Bacterial Endotoxin Testing. The Endosafe PTS is the newest endotoxin detection product. It is a rapid; point-of-use test system that utilizes existing FDA licensed LAL reagents in a test cartridge with a hand-held spectrometer. The PTS can effectively be used to obtain fast, quantitative LAL test results at the point of sample collection. The assessment of samples in multiple locations can be completed efficiently and accurately. Also reagents have a short storage life once opened and can expire before another sample is analyzed. The lack of the Endosafe-PTS equipment would jeopardize the sample analysis, and increase the cost of running Bacterial Endotoxin Test. CHARACTERISTICS The device is licensed by the FDA as an alternative to traditional LAL testing methods for in-process and final product release testing. The PTS utilizes 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. The cartridges are manufactured in a qualified class 100,000 GMP manufacturing area according to rigid quality control procedures ensuring test accuracy and product stability. The PTS instrument is a lightweight, incubating spectrophotometer that has many features which includes a rechargeable power block, easy to read display screen, keypad operation, storage of 100 test results, data transfer ability to standard reports and trending software applications, printable results, and protective case with cover. The speed of the device creates an effective range of product applications, which includes pharmaceutical, biological, nuclear medicine samples, dialysis samples, stem cell materials, laboratory water systems, cleaning validations, and medical devices. The high performance device performs well above other innovative devices, and very effective due to various advantages. The following is a list of the device advantages: •Portable, hand held LAL test system •Fast results at sample collection sites •Simple, one button operation •Single step, quantitative LAL test •Results in about 15 minutes •LAL test components all included •Detects between 0.05-5 EU/mL and 0.10-1 EU/mL •Data downloadable to a central PC Training of new users, unskilled in microbiology, is fast and easy, as the PTS operates with the push of a button. Results are obtained quickly, which will prevent costly delays in research of production. REQUIREMENT 1 PTS 650 PTS Endoscan V Software, PTS 2005F 05 Sensitivity, W130 LAL Reagent Water DELIVERY MUST BE INCLUDED IN PRICE!!! ****************************************************************************************************************** Interested sources shall submit all price, descriptive literature and technical proposals, to Michelle Street, (Contract Specialist), email: Michelle.Street@fda.hhs.gov, or alternate Gina Jackson (Contracting Officer), email: Gina.Jackson@fda.hhs.gov. Mail proposal to: Food and Drug Administration, ATTN: Michelle Street, 5630 Fishers Lane, FHA-500, Room 2129, Rockville, MD 20857. Please indicate the solicitation number on the outside of your package. Any incomplete responses or responses received after the closing will not be accepted. Faxed copies of proposal package will not be accepted. The coversheet to the proposal shall have the offeror’s information. The price and technical proposal shall only have the solicitation number. Closing date for receipt of proposals is July 14, 2009 at 12:00P.M. EST. Questions pertaining to the solicitation may be submitted via email only. Please include the solicitation number on all correspondences. Phone calls will not be accepted. All questions must be in writing and must be received by July 12, 2009. A consolidated question and answer (Q&A) will be posted on website http://www.fbo.gov on July 13, 2009. In order to comply with the Debt Collection Improvement Act of 1996, all contractors must be registered in the Central Contractor Registration (CCR) to be considered for an award of a federal contract. For information regarding registration, contact the CCR website at www.ccr.gov. The FAR requires that prospective contractors complete electronic annual representations and certifications in conjunction with their required registration in the CCR database. These Annual Representations and Certifications are submitted via the Online Representations and Certifications Application (ORCA), a part of the Business Process Network (BPN). To register in ORCA, you need to have an active Central Contractor Registration (CCR) record, a Marketing Partner Identification Number (MPIN and your CCR records, and know your DUNS number. Detailed information regarding ORCA and how to submit records is available on the ORCA website at http://orca.bpn.gov under Help and FAQs. *******FAR CLAUSE 52.211-6 Brand Name or Equal******** As prescribed in 11.107(a), insert the following provision: Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation. (b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must— (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by— (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1060040/listing.html)
- Place of Performance
- Address: 60 Eighth Street NE, Atlanta, Georgia, 30309, United States
- Zip Code: 30309
- Zip Code: 30309
- Record
- SN01869821-W 20090711/090709235358-d42010e5e1b50d29691ee7c7c91598bb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |