FDA grants 510(k) clearance to strips that measure HDL cholesterol
The FDA granted a 510(k) clearance for expanded approval of the PTS Panels lipid panel test strips for measuring high-density lipoprotein (HDL) cholesterol.
PTS Diagnostics, which manufactures the strips and biometric testing devices, announced the approval on April 4.
The PTS Panels can measure from 20 mg/dL to 120 mg/dL for HDL cholesterol, according to the company.
With the approval, PTS Diagnostics said its CardioChek lipid analyzers could serve approximately 98 percent of adults. The company added that its CardioChek analyzers and PTS Panels provided on-site results in as little as 90 seconds via a fingerstick.
The PTS Panels measure HDL cholesterol, total cholesterol and triglycerides. Meanwhile, the handheld CardioCheck lipid analyzers can simultaneously test lipid profiles and glucose and has wireless communications that can transfer data.
In July 2016, Sinocare acquired PTS Diagnostics for $110 million in cash plus a potential additional $90 million based on certain milestones the company could meet in the 18 months after the deal’s closure.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.