FDA product code QDC: Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
QDC is the FDA product code for dna-based test for minimal residual disease for hematologic malignancies. It is a Class II device, regulated under 21 CFR 866.6100 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under QDC. The average 510(k) review took 216 days (median 216). 1 De Novo request was granted under it.
Definition
A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies |
| Device class | Class II |
| Regulation | 21 CFR 866.6100 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for QDC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 216 |
Compare with all 510(k) review times · Search every QDC clearance
Top QDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adaptive Biotechnologies Corporation | 1 | 2020-08-05 |
Most recent QDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200009 | Adaptive Biotechnologies Corporation | Adaptive Biotechnologies clonoSEQ Assay | 2020-08-05 | 216 |
Recalls for QDC devices
openFDA lists no recalls for product code QDC.
Frequently asked questions
What is FDA product code QDC?
QDC is the FDA product code for dna-based test for minimal residual disease for hematologic malignancies. It is a Class II device, regulated under 21 CFR 866.6100 and reviewed by the Pathology panel.
What device class is QDC?
Class II, regulation 21 CFR 866.6100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDC?
Across 1 cleared submissions the average was 216 days from receipt to decision (median 216).
Which companies have the most QDC clearances?
Adaptive Biotechnologies Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDC
- Run a recall and safety report across every QDC manufacturer
- Watch product code QDC 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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