PROCEDURE MANUAL
____________________________________________________________________________
Product Code: CD-BG1
Rev01.06042018
Page
1
of
20
Lab Name:
Procedure #:
Procedure:
CLIA Complexity: WAIVED
Prepared By
Date Adopted
Supersedes Procedure #
Review Date
Revision Date
Signature
Distributed to
# of Copies
Distributed to
# of Copies
This Procedural Bulletin is intended to provide a ready outline reference for performance of the assay. It is
the obligation of every manufacturer of medical devices labeled FOR
IN VITRO
DIAGNOSTIC USE to
provide a complete package insert in accordance with FDA labeling regulation (21 CFR 809.10). Prepared
in accordance with the guidelines recommended by the Clinical and Laboratory Standards Institute,
Wayne, PA 19087; CLSI Document GP2-A2.
Clarity Diagnostics provides CLSI procedures for your use. The procedures are required to
include the same information as listed in the package insert. Any modifications to this document
are the sole responsibility of the Laboratory.
CLIA Complexity: WAIVED
Intended Use:
Clarity BG1000 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose
in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare
professionals as an aid in the management of diabetes, and may be used for testing multiple patients in
clinical setting
.
