| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
7-284
|
| Standard | |
CLSI EP37 1st Edition
Supplemental Tables for Interference Testing in Clinical Chemistry |
|
Scope/Abstract| The supplemental tables presented in EP37 are intended for use with the evaluation procedures presented in CLSI document EP07. The supplemental table in EP37 provide recommended test concentrations for analytes and endogenous substances that may interfere in measurement procedures. |
|
| 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| FDA recognition of CLSI EP37 1st Edition [Rec# 7-284] will be superseded by recognition of CLSI EP37 2nd Edition [Rec# 7-348].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
|
|
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. |
