| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
7-332
|
| Standard | |
CLSI AUTO01-A
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
|
Scope/Abstract| This document provides standards for the design and manufacture of specimen containers and carriers used for collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory automation systems. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §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)
| InVitro Diagnostics (primary) |
| Software/Informatics |
|
| *These are provided as examples and others may be applicable. |
