| CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 13-26 |
| 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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This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.2100 | Calculator/Data Processing Module, For Clinical Use | Class 1 | JQP |
| Automated instrumentation under: Part 862 Clinical Chemistry and Clinical Toxicology Devices Part 864 Hematology and Pathology Devices Part 866 Immunology and Microbiological Devices | |||
| There is no relevant guidance developed at this time. |