DeviceClearance

Product code OJQ— Cardiovascular

ALLOMAP MOLECULAR EXPRESSION TESTING

Classification name
Cardiac Allograft Gene Expression Profiling Test System
Device class
Class 2
Regulation
21 CFR 862.1163
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.”

— U.S. Food and Drug Administration, device classification record for product code OJQ under 21 CFR 862.1163, via openFDA

Market context for product code OJQ

FDA has cleared 2 devices under product code OJQ between 2008 and 2023, 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 OJQ

Recent clearances under product code OJQ

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