Product code PVQ— Microbiology

“An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.”

FDA has cleared 1 device under product code PVQ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Centers For Disease Control and Prevention (CDC)1 clearance

• K170940 — Rickettsia Real-time PCR AssayCenters For Disease Control and Prevention (CDC)·2017-06-29