Amendment 0001 FL MICROSCOPE 1227660 06112020.pdf

Date: June 11, 2020

75F40120Q00052 Amendment One Wide Field Fluorescence Inverted Microscope

Subject: Questions and Responses to 75F40120Q00052 (Wide Field Fluorescence Inverted

Microscope for investigating flow issues in microfluidic channels)

Description:

The purpose of this Amendment 0001 is to do the following:

1. To provide final responses to the questions received for the RFQ. No: 75F40120Q00052 as part of the amendment.

a. Question 1: A.1: A touchscreen display interface on the microscope

Answer: This feature shall allow FDA to rapidly fine-tune the microscope as FDA operate complex flow systems concurrently. The flow-based microfluidic devices that FDA shall be using require constant adjustments and direct hands-on access. Having the aperture and lighting controls operate independent of the computer allows FDA to better contain the contamination area during active handling of blood cells, thus minimizing the contact area with the microscope and potentially vibration.

b. Question 2: E.1 At a minimum 2-axis travel range of X≥120mm and Y≥75mm. E.4:

Maximum Stage Velocity >450mm/w

Answer: The stage shall have motorized as well as manually controlled movement for diversity. The stage shall be able to reproducibly return to the desired location with high resolution of ≤ 5 μm and have high absolute X- and Y-precisions (< 1 μm) to maintain consistency and reproducibility in data collection. The ability to program the rapid movement of the stage under a user-defined protocol is also important for complex microfluidic device testing. As the programmed stage moves in the domain, the system shall adapt and focus automatically to capture images at different locations in the domain. The stage shall travel a range of X ≥ 120 mm and Y ≥ 75 mm to enable the microscope to scan large, complex microfluidic devices beyond the size of a 96-well plate. The high stage velocity is required to rapidly image locations within different devices connected to each other (organ-on-chip devices), as well as to rapidly ‘jump’ between points on a single channel for individual cell tracking at various locations within custom devices.

c. Question 3: B.4 and A.9 N.A. Numerical Aperture Objectives and Techniques: There are a few items that aren’t clear in the specification that I am asking for help with. Section B lists multiple objectives and their intended technique as follows:

Hoffman Modulation Contrast, which is listed in the specification as A.9, is not listed for any of the objectives. c.1. Are we to assume that Hoffman is not necessary? c.2. Does the spec mean that the system only need to be able to “upgrade” to Hoffman in the future?

c.3. Can this list be modified so that all companies can meet it?

Answer: Capability clarification: The instrument shall be used for assessing fluid and particle flows in microchannels at high speeds and shear stresses. The instrument’s user shall be able to specify the region of interest (e.g. square and rectangular ROIs) when using high acquisition frame rates. The ability to control and modify the shape and size of the ROI shall be important when studying biomedical applications such as rapid micro-droplet formation. At a reduced region of interest (ROI), the frame rate should be ≥ 800 frames per second. The FDA has placed the salient characteristics for the FDA’s need in the solicitation that should be addressed in an Offeror’s quote.

2. K. Instructions to Offeror for Quote Submission:

QUOTES DUE: All quotes are due, electronically to Patricia.Natividad@fda.hhs.gov for the RFQ no later than June 18, 2020, 10:00 a.m. Eastern Standard Time.

All other terms and conditions outlined in the Request for Quote (RFQ) remain unchanged.

mailto:Patricia.Natividad@fda.hhs.gov mailto:Patricia.Natividad@fda.hhs.gov mailto:Patricia.Natividad@fda.hhs.gov mailto:Patricia.Natividad@fda.hhs.gov