Extract to table
Pull the structured facts out of a document: parties, dates, amounts, obligations.
Extract to table / pre-sub-package-testing-plan.docx
pre-sub-package-testing-plan.docx
Parties
Solstice Biomedical Inc
Solstice Biomedical Devices Ltd
Harkness LLP
Pinnacle Regulatory Consulting Group LLC
Whitmore Laboratories Inc
Meridian Conformity Assessment GmbH
Dates
June 16, 2025
August 14, 2025
June 18, 2022
March 7, 2024
November 14, 2019
March 3, 2025
September 12, 2024
August 31, 2025
September 15, 2025
Amounts
$485,000
Obligations
The sensor response shall demonstrate a correlation coefficient (r²) of at least 0
The acceptance criteria for precision are as follows: • At glucose concentrations greater than 100 mg/dL: coefficient of variation ("CV") shall not exceed 5%
• At glucose concentrations equal to or less than 100 mg/dL: the standard deviation of measurements shall not exceed 10 mg/dL
No tested substance shall produce a clinically significant bias in glucose measurement
Clinically significant bias is defined as follows: • At glucose concentrations equal to or less than 100 mg/dL: bias shall not exceed ±10 mg/dL
• At glucose concentrations greater than 100 mg/dL: bias shall not exceed ±10% of the reference glucose value