DeviceClearance

Product code PRE— Microbiology

SeptiCyte RAPID

Classification name
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.”

— U.S. Food and Drug Administration, device classification record for product code PRE under 21 CFR 866.3215, via openFDA

Market context for product code PRE

FDA has cleared 4 devices under product code PRE between 2017 and 2025, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code PRE

Recent clearances under product code PRE

Data sourced from openFDA. This site is unofficial and independent of the FDA.