FDA grants waivers to Abaxis for point-of-care analyzers

UNION CITY, Calif. The Food and Drug Administration has given blood-analysis system manufacturer Abaxis a waived status for two analytes, creatine kinase and phosphorus, when used by healthcare professionals with the Piccolo and Piccolo Xpress point-of-care analyzers, Abaxis said last week.

The company said Thursday that as a result of the waived status, healthcare professionals have better access to the Renal Function and MetLyte 8 panels and can conduct this testing at the point-of-care under a certificate of waiver.

“The waiver of these two panels bolsters our already comprehensive offering to healthcare professionals, enabling them to conduct important testing at the point of care in order to manage patients in real time,” Abaxis chairman and chief executive officer Clint Severson said in a statement. “We believe rapid and accurate diagnostic testing can lead to improved patient care while reducing some of the administrative burden healthcare practices face on a daily basis.”

The panels are respectively used to determine renal function status and to assess several metabolic conditions across several medical specialties, including pediatrics and cardiology.