Employee Wellness Screening

Does anyone have any experience with setting up testing for employee wellness screening? I would like suggestions for waived instruments for lipids, glucose and hgb A1C testing. They must be cleared for this type of use. Could the Cardiochek be used for lipids/glucose? I can’t find a suitable A1C analyzer. Perhaps there aren’t any as I believe most, if not all, are to be used for diabetes monitoring only. Thank you.

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FDA only allows POC HbA1c devices for management and monitoring of patients with diabetes; no screening or diagnosis.

The response regarding the FDA regs is correct.  If the statement in the manufacturer's intended use if for monitoring diabetes, than that's all you can use it for.  You should also check with your state regarding your CLIA liscense.  Here in Arizona, if you're performing offsite testing, or fairs for the community onsite, you'd need to apply for what CLIA calls a "Temporary Testing Site Waiver".  It's separate from your certificate of waiver, and information regarding the test date and your CLIA number will be required. 

The Cholestech LDX provides a cartridge that does TC, HDL and Glucose and is waived.

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