| CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 7-259 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Partial Recognition - The following part(s) of the standard is (are) not recognized: Section 2.7.2 Digital Pathology Section 2.7.3 Telepathology |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Shyam Kalavar FDA/OMPT/CDRH/OIR/DMGP/MPCB/ 301-796-6807 shyam.kalavar@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Section 2.7.2 is in conflict with an existing regulation. See regulation below. Section 2.7.3 is in conflict with an existing published final guidance. See Description and Test Methods for Each Component in sections IV(A), IV(B) and IV(C) of the guidance document cited below.
This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.3800 | Stainer, Tissue, Automated | Class 1 | KEY |
| §864.3600 | Light, Microscope | Class 1 | IBJ |
| §864.3300 | Cytocentrifuge | Class 1 | IFB |
| §864.3010 | Slides, Microscope | Class 1 | KEW |
| §864.1850 | Stain, Ponceau | Class 1 | HZO |
| 21 CFR 864.3700 Whole Slide Imaging System. Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff, Issued on April 20, 2016. |