PTS Diagnostics Announces New FDA 510(k) Clearance for Extended HDL Range Lipid Panel Test Strips

April 5, 2017 — PTS Diagnostics announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded top range for measurement of HDL cholesterol (HDL) to 120 mg/dL (3.1 mmol/L) for the company's PTS Panels lipid panel test strips. The PTS Panels lipid panel test strip now has a measurement range of 20 to 120 mg/dL (0.52 to 3.1 mmol/L) for HDL. Additionally, the lipid panel shelf life has increased due to the use of new test strip vials.

This change means the CardioChek lipid analyzers can now serve about 98 percent of the adult population, expanding the device’s ability to provide results for those individuals who tend to have higher HDL (good) cholesterol.

“While very much desired in the United States, there is significant global customer demand for our CardioChek system to measure higher HDL cholesterol levels,” said Robert Huffstodt, president and CEO of PTS Diagnostics. “Especially in countries like China, guidelines require an LDL measurement for all patients who get a lipid panel test, which can sometimes be difficult if HDL ranges are too high. For individuals with very healthy HDL cholesterol above 100 mg/dL, our customers have relied on retesting with venous blood to obtain LDL results. This expansion to our upper range for HDL will result in more LDL results being available and should eliminate a lot of retesting and the associated cost and inconvenience. This will create even greater efficiencies.”

CardioChek analyzers and PTS Panels test strips have a proven success record of providing lab-quality results in as little as 90 seconds, all from a fingerstick.

PTS Panels lipid panel test strips measure total cholesterol, HDL cholesterol and triglycerides, and allow calculation of LDL cholesterol and TC/HDL ratio. No refrigeration of reagents is needed, which now have a shelf life of 20 months from the date of manufacture. The CardioChek Plus system and PTS Panels test strips are stored at room temperature. This handheld, battery-operated analyzer is compact and lightweight, making it easy to transport and store.

CardioChek systems are CLIA-waived and meet NCEP guidelines for accuracy and precision. The CardioChek Plus analyzer, which offers simultaneous testing of lipid profile and glucose, has wireless communication capabilities which simplify data transfer. In addition, the CardioChek Plus analyzer is CRMLN-certified for cholesterol and HDL cholesterol testing.

For more information: www.ptsdiagnostics.com