Page Comparison

There is quite a bit of push back on this data element

Should support testkit and instrument device identifiers, in order to accommodate different patterns

Issues this data element is aiming to solve:

• Linking instance data to LIDR entries

• Identifying test kit issues for EUAs to better understand these new tests or in post market surveillance of 510k = Real World Data

• Allowing to decide if results can be combined (harmonized methods)

  • need to determine the key items needed for this effort

  • CDC’s Harmonization effort for lipid testing has been tracking instrument and reagents and calibrators at the lot number level - but has not been seeing much benefit of tracking this at the lot level

    • the list of parameters that helps them find what is comparable: https://www.cdc.gov/labstandards/csp/pdf/crmln/MFR_TC-AK_CRMLN-508.pdf

      • seems to be manufacturer and model - if taking off the lot numbers etc

What level of identification is needed:

• manufacturer / model

• Global Trade Identificatin Number (GTIN) - provided by GS1 - can be used as UDI

• UDI

  • device identifier

  of UDI

  • production identifier

  of UDI

  • (serial number or lot number)

  • full UDI

Lab tests not covered by UDI

...