| CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification |
| Recognition Date | 2008-09-09 |
| Recognition List | 020 |
| Recognition Number | 13-9 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | Software/Informatics |
| FDA Tech | James Mullally FDA/OMPT/CDRH/OIR/DCTD/CTXB/ 240-402-5021 james.mullally@fda.hhs.gov |
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Clinical and Laboratory Standards Institute document AUTO2-A2 - Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard - Second Edition defines the way bar-coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar-code labels on specimen container tubes that are used on clinical laboratory analyzers. However, due to the current diversity of patient data, the informational content that is used to identify the specimen has not been specified. This specification will also meet the requirement for laboratory automation systems. It enables the production of reliable bar-coded symbols that are readable by any complying clinical laboratory analyzer and automation system.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.3250 | Container, Specimen Mailer And Storage, Sterile | Class 1 | KDT |
| §864.3250 | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | Class 1 | KDW |
| §864.3250 | Container, Specimen, Sterile | Class 1 | FMH |
| §862.2100 | Calculator/Data Processing Module, For Clinical Use | Class 1 | JQP |
| There is no relevant guidance developed at this time. |