Employee Wellness Screening

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.

You may have already been down this road, but as someone who had been asked about adding employee wellness testing years ago ( it was never realized), be sure to thoroughly challenge your employee health department on whether such testing is truly needed to be performed at the POC.  Unless counseling/therapy/treatment is initiated on site (i.e., is there a physician or mid-level practitioner on site), it may not be a true need.  When we did some investigating, we found that the whole request came to be as a result of a vendor visit (Cholestech) trying to sell their product.  When they were challenged on the true level of need, as well as discovering that state regulations at the time added more regulatory requirements above the federal waived requirements, the whole thing was dropped.  They already were getting <1 day turnaround for this testing from a local reference lab and when they really looked at their situation, they realized this was more than adequate, and the issue was never brought up again.