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Victoria Nawrocki posted a reply on Re: Employee Wellness Screening

Thursday, Dec 7, 2017 at 12:28 PM

Said: : "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. Her...

Brian Hearne posted a reply on Re: Employee Wellness Screening

Thursday, Dec 7, 2017 at 6:21 AM

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

Brian Hearne posted a reply on Re: Waived HgbA1c testing options

Thursday, Dec 7, 2017 at 6:18 AM

Said: : "may be portable, but since its inception, the accuracy and precision is not what most clinicians accept for the management of patients with diabetes."

Brian Hearne posted a reply on Re: Waived HgbA1c testing options

Thursday, Dec 7, 2017 at 6:17 AM

Said: : "by FDA regs, no point of care test is allowed to be used in a screening situation. All POC A1c are to be used in a monitoring and management capacity only."

Michelle Higgins posted a new Topic

Wednesday, Dec 6, 2017 at 8:20 PM

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 m..."

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