Rightest GM700 Pro 2 - CLIA Complexity; CLIA Waiver Status; Indication for Use; System Intended Use

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CLIA Complexity Indication for Use
This test is WAIVED for capillary (draw from ngertip, palm and forearm) and venous whole
blood under the Clinical Laboratory Improvements Amendments of 1988 (CLIA).
Laboratories with a Certicate of CLIA waiver can perform this test in a waived setting and must
follow the manufacturer’sinstructions for performing the test. If a laboratory modies the test
instructions, the test will no longer be considered waived.
(Refer to the section of "CLIA Waiver Study Results/System Accuracy Result").
This manual provides all necessary instructions for the routine operation and maintenance of the
RIGHTEST Blood Glucose Meter GM700 Pro 2. Please read this manual carefully. It has been
prepared to help you attain optimum performance from your Meter.
The RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 consists of the The RIGHTEST
Blood Glucose Meter GM700 Pro 2 and The RIGHTEST Blood Glucose Test Strip GS770.
The RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 is intended for Point-of-care, in
vitro diagnosis, multiple-patients use for quantitative determination of glucose in capillary blood
(draw from ngertip, palm and forearm) and venous whole blood. Whole blood glucose results
are equivalent to plasma results with biochemical analyzer.
The system is intended for use at clinical environments (ie. genenral primary care centers,
outpatient settings for endocrinology and metabolism).
When testing from the ngertip, only single-use, auto-disabling lanceing device should be used.
For alternative site test, single person use lancing device should be used, and the testing could
only perform during steady state time (when there is no rapid change in glucose).
The system is not intended for the screening or diagnosis of diabetes mellitus.