510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221640Substantially Equivalent

AlloMap Heart Molecular Expression Testing

Caredx AB, Brisbane CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221640 is the FDA 510(k) clearance record for AlloMap Heart Molecular Expression Testing, a class II device, cleared for Caredx, Inc. on under FDA product code OJQ (Cardiac Allograft Gene Expression Profiling Test System). FDA's definition for product code OJQ reads: "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...". FDA records list one 510(k) clearance for Caredx, Inc. As of , FDA records show no recalls naming K221640.

Clearance record

Decision date
Received
(464 days to decision)
Product code
OJQ Cardiac Allograft Gene Expression Profiling Test System
Regulation
21 CFR 862.1163
Device class
Class II
Review panel
Cardiovascular
Applicant
Caredx, Inc. 3260 Bayshore Blvd., Brisbane CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OJQ

Trailing 12 months

FDA records hold no clearances under product code OJQ in the trailing twelve months.

FDA records show no clearances under product code OJQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OJQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260