OJQ · Class II · 21 CFR 862.1163

FDA Product Code OJQ: Cardiac Allograft Gene Expression Profiling Test System

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.

Leading manufacturers include Caredx, Inc..

2
Total
1
Cleared
238d
Avg days
2008
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cardiac Allograft Gene Expression Profiling Test System Devices (Product Code OJQ)

2 devices
1–2 of 2
Cleared Sep 13, 2023
AlloMap Heart Molecular Expression Testing
K221640
Caredx, Inc.
Chemistry · 464d

About Product Code OJQ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code OJQ since 2008, with 1 receiving FDA clearance (average review time: 238 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

OJQ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →