| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
7-348
|
| Standard | |
CLSI EP37 2nd Edition
Supplemental Tables for Interference Testing in Clinical Chemistry |
|
Scope/Abstract| This product is a database tool that updates the first edition of the original CLSI EP37 document and converts the guidance into an interactive application. It continues to provide recommended testing concentrations for analytes and endogenous substances that may affect clinical chemistry measurement procedures. This resource is intended to support and fully aligns with the evaluation procedures outlined in the CLSI EP07. |
|
| 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. |
|
Transition Period
| FDA recognition of CLSI EP37 1st Edition [Rec# 7-284] will be superseded by recognition of CLSI EP37 2nd Edition [Rec# 7-348]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-284] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-284] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §862.1345 |
Hexokinase, Glucose
|
Class 2
|
CFR
|
| §862.1345 |
Glucose Oxidase, Glucose
|
Class 2
|
CGA
|
| §862.1345 |
Glucose Dehydrogenase, Glucose
|
Class 2
|
LFR
|
| §862.1345 |
System, Test, Blood Glucose, Over The Counter
|
Class 2
|
NBW
|
| §862.1345 |
Prescription Use Blood Glucose Meter For Near-Patient Testing
|
Class 2
|
PZI
|
| 21 CFR 58 Good Laboratory Practice for Non-Clinical Studies |
| 21 CFR 820 Quality Systems Regulations |
|
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 Group (STG)
|
| *These are provided as examples and others may be applicable. |
