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The following table summarises the depth of detail required to be contained in the STED for a product undergoing conformity assessment by the TGA. References to Class 4 IVDs in this table indicate the level of detail expected in the design dossier for products undergoing a design examination.
| Section | Class 1 | Class 2 | Class 3 | Class 4 |
|---|---|---|---|---|
| Device description including variants | ||||
| Device description | Address each point - all classes | |||
| Reference to previous device generation - not yet available on any market | SUMMARY | SUMMARY | SUMMARY | SUMMARY |
| Device history - already available on the market in another jurisdiction | SUMMARY | SUMMARY | SUMMARY | SUMMARY |
| Risk analysis and control | SUMMARY / REDUCED TABLE | DETAILED | ||
| Design and manufacturing information | ||||
| Device design | SUMMARY | SUMMARY | SUMMARY | DETAILED |
| Clinical evidence | SUMMARY | SUMMARY | DETAILED | ELABORATE |
| Manufacturing processes | - | - | - | SUMMARY |
| Design and manufacturing sites | SUMMARY | SUMMARY | SUMMARY | SUMMARY |
| Product validation and verification | ||||
| Specimen type | SUMMARY | SUMMARY | SUMMARY | DETAILED |
| Accuracy - Trueness | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Precision - Reproducibility and repeatability | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Traceability of control and control materials | SUMMARY | SUMMARY | SUMMARY | DETAILED |
| Analytical sensitivity | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Analytical specificity | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Measuring range of the assay | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Validation of assay cut-off | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Software | SUMMARY | SUMMARY | SUMMARY | DETAILED |
| Stability | ||||
| Claimed shelf life | SUMMARY | SUMMARY | DETAILED | DETAILED |
| In use stability | SUMMARY | SUMMARY | DETAILED | DETAILED |
| Shipping stability | SUMMARY | SUMMARY | DETAILED | DETAILED |
The following information elaborates on the terms used in the table to describe the depth of detail:
Summary information
- Brief description of protocol
- Study results
- Study Conclusion
Detailed information
- Study protocol
- Method of data analysis
- Study report (summary of external reports)
- Study Conclusion
Elaborated information
- Study protocol
- Method of data analysis
- Study report (all external reports)
- Study Conclusion
- Raw/line data
The following table shows the terms used for the various devices classes in the GHTF document and their equivalents for IVDs under the Australian regulations.
| GHTF IVD Class | Australian IVD Class |
|---|---|
| Class A | Class 1 IVD |
| Class B | Class 2 IVD |
| Class C | Class 3 IVD |
| Class D | Class 4 IVD |
The STED should demonstrate the compliance of the IVD with the Australian legislative requirements. An EP Checklist for the Australian Essential Principles is available on the TGA website.