K221640 is an FDA 510(k) clearance for the AlloMap Heart Molecular Expression Testing. This device is classified as a Cardiac Allograft Gene Expression Profiling Test System (Class II - Special Controls, product code OJQ).
Submitted by Caredx, Inc. (Brisbane, US). The FDA issued a Cleared decision on September 13, 2023, 464 days after receiving the submission on June 6, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1163. 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..
| 510(k) Number | K221640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2022 |
| Decision Date | September 13, 2023 |
| Days to Decision | 464 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | OJQ - Cardiac Allograft Gene Expression Profiling Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1163 |
| 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. |