Operator's Manual

Introduction • 1
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08424705001 (04) 2021-06 USA • Accu-Chek Inform II Operator’s Manual Version 7.2
1 Introduction
1.1 Before you start
CLIA Categorization This is a CLIA Waived system. A Certificate of CLIA
Waiver (or higher) is required to perform the test. Infor-
mation on obtaining CLIA certificates can be found at
www.cms.hhs.gov/clia. Facilities performing testing must
have a CLIA Certificate of Waiver. 42 USC 263a(c)(2).
Laboratories with a certificate of waiver must follow the
manufacturer’s instructions for performing the test.
42 CFR 493.15(e)(1). Any modifications and/or failure
to follow test system instructions, including those for
limitations/intended use and performance of QC testing
as a failure alert mechanism, results in use that is
considered high complexity and subject to all applicable
CLIA requirements. All applicable state and local laws
must be met.
Any adverse reactions experienced with the use of this
product, and/or quality problems should also be reported
to the FDA’s MedWatch Adverse Event Reporting program
online (at www.fda.gov/MedWatch/report.htm), by phone
(1-800-FDA-1088), or by returning the postage-paid FDA
form 3500 (which may be downloaded from www.fda.gov/
MedWatch/getforms.htm) by mail to (MedWatch,
5600 Fishers Lane, Rockville, MD 20852-9787) or fax
(1-800-FDA-0178).
If there are any problems with the Accu-Chek Inform II
System, notify CMS at
http://www.cms.hhs.gov/clia/ro-map.asp