FDA product code OJQ: Cardiac Allograft Gene Expression Profiling Test System
OJQ is the FDA product code for cardiac allograft gene expression profiling test system. It is a Class II device, regulated under 21 CFR 862.1163 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under OJQ, 1 in the last five years. The average 510(k) review took 464 days (median 464). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Allograft Gene Expression Profiling Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1163 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OJQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 464 |
Compare with all 510(k) review times · Search every OJQ clearance
Top OJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Caredx, Inc. | 1 | 2023-09-13 |
Most recent OJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221640 | Caredx, Inc. | AlloMap Heart Molecular Expression Testing | 2023-09-13 | 464 |
Recalls for OJQ devices
openFDA lists no recalls for product code OJQ.
Frequently asked questions
What is FDA product code OJQ?
OJQ is the FDA product code for cardiac allograft gene expression profiling test system. It is a Class II device, regulated under 21 CFR 862.1163 and reviewed by the Clinical Chemistry panel.
What device class is OJQ?
Class II, regulation 21 CFR 862.1163. Typical premarket route: 510(k).
How long does a 510(k) take for product code OJQ?
Across 1 cleared submissions the average was 464 days from receipt to decision (median 464).
Which companies have the most OJQ clearances?
Caredx, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OJQ
- Run a recall and safety report across every OJQ manufacturer
- Watch product code OJQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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