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Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

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Depth of information to be provided

The following table summarises the depth of detail required to be contained in the STED. References to Class 4 IVDs in this table indicate the level of detail expected in the STED for products undergoing a design examination. Class 4 IVDs must be covered by a TGA Conformity Assessment Certificate and are not required to undergo application audit.

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 or REDUCED TABLE DETAILED
Design and manufacturing information
Device design SUMMARY SUMMARY SUMMARY DETAILED
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 specificity & sensitivity SUMMARY SUMMARY DETAILED DETAILED
Validation of assay cut-off SUMMARY SUMMARY DETAILED DETAILED
Stability
Claimed shelf life SUMMARY SUMMARY DETAILED DETAILED
In use stability SUMMARY SUMMARY DETAILED DETAILED
Shipping stability SUMMARY SUMMARY DETAILED DETAILED
Software SUMMARY SUMMARY SUMMARY DETAILED
Clinical evidence SUMMARY SUMMARY DETAILED ELABORATED

The following information provides explanations for the terms used in the table to describe the depth of detail required in the STED:

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

Further information may also be found in the GHTF document:

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