The breakthrough diagnostic test has been designed for the quantitative detection of CRP levels in patient serum.
It uses a finger-prick blood sample and provides lab-quality test results in less than five minutes.
The company noted that easy, quick and accurate test results help to expedite medical treatment.
The regulatory approval represents an important validation for the ProciseDx instrument and CRP test.
ProciseDx expects to obtain FDA approval for other tests next year.
ProciseDx president and chief scientific officer Larry Mimms said: “Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days.
“The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in five minutes or less.
“Our San Diego team has worked exceptionally hard to bring this point of care quantitative immunoassay platform through FDA clearance.”
The company currently offers a menu of five-minute gastroenterology (GI) and Therapeutic Drug Monitoring (TDM) tests in Europe.
It has obtained CE marks for four GI tests that have now been introduced in Europe.
ProciseDx has submitted de novo applications to the FDA for two of its TDM tests.
It also intends to commercialise its GI and TDM tests menu in the US next year and launch Procise ADL, Procise IFX and Procise CRP.
The company has also announced a licensing, commercialisation and manufacturing agreement with Biosynex , its partner and shareholder, that includes Europe and the Middle East.
Under the deal, Biosynex will be responsible for supplying ProciseDx’s products to the company’s existing distributors in the regions. ProciseDx will retain its rights and responsibilities for China, Japan, Canada and the US.