Food and Drug Administration (FDA) approved and Quality Management documented Fentanyl/Norfentanyl Immunoassay Reagent Kits

1. Notice. This Request for Information (RFI) is issued for informational purposes and market research only; it does not constitute a solicitation. The Government will not reimburse any company or individual for any expenses associated with preparing/submitting information in response to this posting, and any costs incurred are not considered allowable direct charges to other contracts or tasking. The information provided may be used by the Government in developing its acquisition strategy, statement of work/statement of objectives, and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained within their response. 2. Scope. The Naval Medical Readiness Logistics Command-Detachment Fort Detrick is conducting market research to identify possible sources in the commercial marketplace capable of providing United States Food and Drug Administration (FDA) approved and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits (hereafter referred to as Reagent/Kit(s)) for use with the currently installed Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. The NAICS Code is 325413 In-Vitro Diagnostic Substance Manufacturing; the Product Service Code is 6550 In Vitro Diagnostic Substances, Reagents, Test Kits and Sets. 2.1. The Kits shall be for the initial (screen) immunoassay* for the detection of fentanyl in urine when present at a concentration equal to or greater than 1 ng/mL using AU5800 Series Clinical Chemistry Analyzers calibrated at 1 ng/mL using DOD FTDTL-prepared and -certified solutions containing fentanyl. *Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division. The DOD intends to use the immunoassay kits in a manner consistent with the FDA approval. The package insert and information for the analyzer settings shall contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device's FDA approval. 2.2. The immunoassay is limited to a two (2) reagent assay procedure. A respondent's reagent which requires a separate pre-treatment of each specimen prior to testing on the analyzer will not be considered acceptable. 2.3. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DODI 1010.16 Rev. (June 15 2020). Immunoassay kits are considered medical devices and shall have clearance from the FDA to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes in the manufacture of the devices. 2.4. The minimum shelf life of any unopened component of the assay shall be at least 180 days from the date of delivery to the FTDTL. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days. 2.5. Respondents shall have the capability of providing sufficient Kits to accommodate approximately 500,000 tests per month for a period of up to three (3) years. 2.6. Quality Assurance Program of the Manufacturing Process. Respondents shall possess current ISO-9000 series (or ISO 13485:2016) certification OR have the ability to provide evidence of a Quality Management System for the FDA approved Kits. 3. Instructions to potential respondents. Interested parties who desire to participate in this RFI are encouraged to submit responses that demonstrate they presently have the experience, capability, and FDA approved Kits meeting the characteristics outlined in above paragraphs 2 through 2.6. 3.1. Respondent Data - Company Information. Company Name Address Point of Contact (include phone number and email address) CAGE Code and Unique Entity Identification Number Web Page URL North American Industry Classification System (NAICS) code relevant to the respondent's company's response and business size (i.e., large business, small business, certified 8(a) concern, veteran-owned, HUBZone, woman-owned, etc.). 3.2. Capability Statement. Describe the product's compatibility with the Beckman Coulter AU5800 series systems and how the Kits meet the requirements in the above paragraphs 2 through 2.6. Indicate name of Kit, product number(s), and manufacturer. Describe the capability (current) and prior history of providing the quantity of Kits to perform approximately 500,000 tests per month, in accordance with respondent's methods of providing Kits. Explain respondent's International Organization for Standardization (ISO) certification (or equivalent QMS). Describe the respondent's method of providing the Kits (100% from respondent, subcontracts (provide subcontract company and CAGE, including percentages). 4. Responses, Communications and Additional Considerations. 4.1. Responses shall not exceed 8 pages (excluding cover page, FDA approval/FDA Indications for Use/510(k) Summary), minimum font of 10, Word or Adobe formats. The submitted documentation becomes the property of the United States Government and will not be returned. 4.2. All information submitted will be adequately safeguarded from unauthorized disclosure in accordance with FAR Part 15.207. Summary papers/responses that fail to comply with the instructions herein or present information not pertaining to the subject or pose questions may not be reviewed. Information submitted in response to this RFI is submitted at no cost to the Government. 4.3. Responses shall be provided no later than 15 days after the posting of this notice, as provided in the notice's posting. Responses shall be submitted via email to cheryl.r.vendemia.civ@health.mil. No phone calls will be accepted and no questions will be considered.