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PTS Dx Gets FDA Clearance for Extended HDL Range on Lipid Panel

NEW YORK (360Dx) – PTS Diagnostics said today that the US Food and Drug Administration has given 510(k) clearance that expands the top of the range for measurement of HDL cholesterol on PTS Panels, its point-of-care lipid panel test strips. The top of the range is now 120 mg/dL, and the new measurement range is 20 to 120 mg/dL, or 0.52 to 3.1 mmol/L.

PTS Diagnostics said that because of the new HDL-range, its CardioChek lipid analyzers can serve about 98 percent of the adult population, which expands access for people who tend to have high HDL, or good, cholesterol.

PTS Diagnostics CEO Robert Huffstodt said in a statement that the new HDL range extension also allows a broader range of calculated LDL results than its lipid analyzer could previously report.

The firm noted that its CardioChek analyzers and PTS Panels test strips provide lab-quality results from a finger stick in around 90 seconds. Its analyzers provide rapid on-site blood chemistry values and measurements to help identify at-risk individuals. Its lipid panel test strips measure total cholesterol, HDL cholesterol, and triglycerides, and allow calculation of LDL cholesterol and TC/HDL ratio.

The CardioChek Plus system tests lipid profile and glucose simultaneously, and provides results "using the same technology as clinical laboratories," the firm said.

Huffstodt said that that to obtain FDA clearance, the firm hasn't changed the test strips' chemistry, but it presented additional data to support expanding the measuring range.

CardioChek systems are CLIA-waived and meet NCEP guidelines for accuracy and precision, the firm said. It also noted that it has extended its lipid panel shelf life using new test strip vials.