Device Atlas

AlloMap Heart Molecular Expression Testing

Q: What is the product code of K221640?

The FDA product code is OJQ – Cardiac Allograft Gene Expression Profiling Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1163.

FDA 510(k) K221640 · Caredx, Inc.

Substantially Equivalent

510(k) numberK221640

Submission

Device name: AlloMap Heart Molecular Expression Testing
Applicant: Caredx, Inc.
Brisbane, CA, US
Received: June 6, 2022
Decision date: September 13, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OJQ – Cardiac Allograft Gene Expression Profiling Test System
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1163
Specialty: Cardiovascular

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)…

Questions and answers

When was AlloMap Heart Molecular Expression Testing cleared by the FDA?

AlloMap Heart Molecular Expression Testing (K221640) received a 510(k) decision of Substantially Equivalent on September 13, 2023, 464 days after the submission was received.

What is the product code of K221640?

The FDA product code is OJQ – Cardiac Allograft Gene Expression Profiling Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1163.