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Unique Testkit Device Identifier Feedback for USCDI+/USCDI

Unique Testkit Device Identifier Feedback for USCDI+/USCDI

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

What level of identification is needed:

  • manufacturer / model

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

  • UDI

    • device identifier

    • production identifier (serial number or lot number)

    • full UDI

Lab tests not covered by UDI

Hematology analyzer example (e.g. from Abbott, Coulter, Sysmex).

Used to produce results from CBC panel order

  1. https://loinc.org/58410-2/

  2. Some are directly measured by the instrument, while others are calculated on the instrument.

Instrument (large footprint for high volume//large labs):

image-20240216-233223.png