NOI_FDA-SS-117003.pdf

NOTICE OF INTENT TO SOLE SOURCE

Date: March 23, 2023 Subject: Repair Parts and Components for existing 908 Devices Rebel CE-MS system (Serial No. R289)

FDA ID: NOI_FDA-SS-117003

This is a notice that the U.S. Food & Drug Administration (FDA) intends to issue a purchase order to 908 Devices, 645 Summer Street, Boston, MA 02210. The Government intends to issue a sole source award in accordance with FAR 13.501(a)(1)(ii).

The NAICS Code is: 334516- Analytical Laboratory Instrument Manufacturing.

TECHNICAL REQUIREMENTS:

1. Shall provide Original Equipment Manufacturer (OEM), BRAND NAME or EQUAL, and parts components (see Table A) that are compatible with the 908 Devices Rebel CE-MS system (Serial No. R289) that meets the following description:

• The REBEL Cell Culture Media Analyzer is a self-contained, benchtop device that offers automated at-line analysis and quantitation of >30 amino acids, biogenic amines, vitamins, and dipeptides in spent culture medium using a single ≤10 µL fresh or spent medium sample in only 7 mins. This is accomplished by utilizing an integrated microfluidic capillary electrophoresis (CE) separation system coupled to a miniature ion-trap mass spectrometer.

2. Shall meet the delivery timelines as listed in Table A.

Table A Q1 Shipment: Within 7 days of Award

Part No. Description Quantity 850-00050 Rebel SMA Kit 3

Q2 Shipment: 90-120 Days Post-Award

Q3 Shipment: 180-210 Days Post-Award

Q4 Shipment: 270-300 Days Post-Award

This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to 908 Devices, within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: April 3, by 8:00AM (EST). Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.

mailto:nicole.craig@fda.hhs.gov