Attachment 7 Technical Compliance Matrix.docx

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Attached to
Maxwell RSC 48 DNA Extraction Systems or Equal – Commercial Blanket Purchase Agreement (BPA)
Solicitation number
HFP-2026-133524-75F40126Q00256
Issued by

About this file

This is a Technical Compliance Matrix template that offerors must complete to demonstrate how their proposed Maxwell RSC 48 DNA Extraction Systems or equivalent products meet the specified technical requirements for a Commercial Blanket Purchase Agreement (BPA) issued by the Department of Health and Human Services Food and Drug Administration under Solicitation Number HFP-2026-133524.

The matrix requires offerors to certify compliance with 16 core technical requirements, including processing up to 48 samples per run with a processing time of 30 minutes or less, automated extraction without spin columns, UV decontamination capability, inclusion of a Quantus Fluorometer or equivalent, and suitability for FDA-validated molecular rapid methods. Additional compliance sections address delivery and installation requirements, including delivery to all FDA laboratory locations, inside delivery, installation by qualified field engineers, operational testing, and on-site training for up to three users per location. The matrix also includes a Buy American compliance section requiring offerors to specify whether the equipment is a domestic or foreign end product and whether applicable trade agreement exceptions apply. Offerors must provide references to specific pages or sections in their technical documentation supporting each compliance claim, include an authorized representative's certification that the information is accurate and complete, and submit accompanying technical documentation. The government evaluation section designates space for evaluators to mark technical acceptability as pass or fail, with dated evaluator sign-off and comments required.

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Other files

File Type Posted
Attachmen 5 Buy American Certificate.docx DOCX document
Attachment 4 - SF18.pdf PDF
Attachment 1 - BPA Solicitation Maxwell .docx DOCX document
Attachment 6 Past Performance Reference Form.docx DOCX document
Attachment 2 - PWS.docx DOCX document
Attachment 3 - Pricing_Schedule.xlsx XLSX spreadsheet

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ATTACHMENT 7 – TECHNICAL COMPLIANCE MATRIX

Solicitation Number: HFP-2026-133524 Maxwell RSC 48 DNA Extraction Systems BPA Instructions: Offerors shall complete this Compliance Matrix and identify how the proposed equipment meets or exceeds each requirement. References shall identify the specific page, section, or attachment where compliance is demonstrated. You may modify to include any additional information as necessary to determine compliance to the requirement.

Req. No.
Requirement
Comply

(Yes/No) Exceeds (Yes/No)

Reference (Page/Section)
Offeror Comments
1
Processes up to 48 samples per run
☐ Yes ☐ No
☐ Yes ☐ No
2
Processing time 30 minutes or less
☐ Yes ☐ No
☐ Yes ☐ No
3
Automated extraction; no spin columns required
☐ Yes ☐ No
☐ Yes ☐ No
4
Minimizes shearing, clogged tips, and contaminating drips
☐ Yes ☐ No
☐ Yes ☐ No
5
Preloaded application software included
☐ Yes ☐ No
☐ Yes ☐ No
6
UV decontamination capability
☐ Yes ☐ No
☐ Yes ☐ No
7
Quantus Fluorometer or equivalent included
☐ Yes ☐ No
☐ Yes ☐ No
8
Required deck trays included
☐ Yes ☐ No
☐ Yes ☐ No
9
Suitable for FDA validated molecular rapid methods
☐ Yes ☐ No
☐ Yes ☐ No
10
New equipment; not refurbished or demo unit
☐ Yes ☐ No
☐ Yes ☐ No
11
Minimum one-year warranty
☐ Yes ☐ No
☐ Yes ☐ No
12
Warranty response within two business days
☐ Yes ☐ No
☐ Yes ☐ No
13
On-site service within five business days
☐ Yes ☐ No
☐ Yes ☐ No
14
Delivery within 90 calendar days
☐ Yes ☐ No
☐ Yes ☐ No
15
Installation within 14 calendar days
☐ Yes ☐ No
☐ Yes ☐ No
16
On-site training for up to three users per location
☐ Yes ☐ No
☐ Yes ☐ No

SECTION B – DELIVERY AND INSTALLATION COMPLIANCE

Requirement
Comply
Reference
Comments
Delivery to all FDA laboratory locations
☐ Yes ☐ No
Inside delivery provided
☐ Yes ☐ No
Installation by qualified field engineers
☐ Yes ☐ No
Operational testing completed
☐ Yes ☐ No
Installation report provided
☐ Yes ☐ No
Training materials provided
☐ Yes ☐ No

SECTION C – BUY AMERICAN COMPLIANCE

Domestic End Product
☐ Yes ☐ No

Country of Origin

Foreign End Product Offered
☐ Yes ☐ No
Trade Agreement Exception Applicable
☐ Yes ☐ No

SECTION D – OFFEROR CERTIFICATION

I certify that the information contained in this Compliance Matrix is accurate, complete, and supported by the accompanying technical documentation submitted with this quotation.

Company Name: ______________________________________________

UEI: _______________________________________________________

Authorized Representative: __________________________________ Title: ______________________________________________________ Signature: _________________________________________________ Date: ______________________________________________________

SECTION E – GOVERNMENT USE ONLY

Technical Acceptability: ☐ Pass ☐ Fail Evaluator: ________________________________________________ Date: _____________________________________________________ Comments: ________________________________________________ 2 | Page

File details come from the government source that posted it. Updated .