1.1 Number

1.2 Purpose of submission

1.3 Measured

1.4 Type of test

1.5 Applicant

1.6 Proprietary and Established Names

1.7 Regulatory Information

1.8 Intended Use

1.9 Device Description

1.10 Standard/Guidance Documents Referenced

1.11 Test Principle

1.12 Performance Characteristics

1.13 Instrument Names

1.14 System Description

1.15 Other supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section

[Performance Characteristics][#performance-characteristics]

1.16 Proposed Labeling

1.17 Identified Risks to Health and Required Mitigations

1.18 Benefit/Risk Analysis