PCL, a Kosdaq-listed in vitro diagnostic medical device company, said Thursday that its AI-based point of care testing (POCT) device, Pclok II Prep Universal, characterized by the ability to diagnose various chronic diseases, cancers, viruses, and infectious diseases, has received U.S. FDA clearance.

Pclok II Prep Universal is a fully automated system that automatically detects and pre-processes blood, urine, saliva, and nasal fluid collected from the human body based on AI, enabling faster and easier diagnosis on-site.

Pclok II Prep Universal is an improved version of Pclok II, which was approved in the U.S. in December 2020, in terms of sensitivity and accuracy.

It also has the potential to be utilized as a home medical device in the future, considering its accuracy and user convenience, the company said.

According to U.S. business consulting firm Frost & Sullivan, the in vitro diagnostics market is expected to grow at an annual growth rate of 6.9 percent from $99.2 billion in 2021 to $138.3 billion in 2026.

Pclok II Prep Universal is a single platform that integrates immunoassay and clinical chemistry to perform immunodiagnostics, utilizing antigen and antibody responses.

Meanwhile, based on Pclok II Prep Universal and Pclok II, which have been approved by the U.S. FDA, PCL will participate in CES 2024, a world-scale electronics expo to be held in January next year, to accelerate its entry into the U.S. as an in vitro diagnostics company.