| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
020
|
Date of Entry 09/09/2008
|
|
FR Recognition Number
|
13-9
|
| Standard | |
CLSI AUTO2-A2
Laboratory Automation: Bar Codes for Specimen Container Identification |
|
Scope/Abstract| 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. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
| §864.3250 |
Container, Specimen, Sterile
|
Class 1
|
FMH
|
| §864.3250 |
Container, Specimen Mailer And Storage, Sterile
|
Class 1
|
KDT
|
| §864.3250 |
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
|
Class 1
|
KDW
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
FDA Specialty Task Groups (STG)
| Software/Informatics (primary) |
| InVitro Diagnostics |
|
| *These are provided as examples and others may be applicable. |
