FDA product code QDI: Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
QDI is the FDA product code for fish based detection of chromosomal abnormalities from patients with hematologic malignancies. It is a Class II device, regulated under 21 CFR 864.1880 and reviewed by the Pathology panel. Devices under QDI reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for QDI devices, 1 initiated in the last five years.
Definition
Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional.
Classification
| Field | Value |
|---|---|
| Device name | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
| Device class | Class II |
| Regulation | 21 CFR 864.1880 |
| Review panel | PA — Pathology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for QDI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-01-18.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QDI?
QDI is the FDA product code for fish based detection of chromosomal abnormalities from patients with hematologic malignancies. It is a Class II device, regulated under 21 CFR 864.1880 and reviewed by the Pathology panel.
What device class is QDI?
Class II, regulation 21 CFR 864.1880. Typical premarket route: 510(k).
Have QDI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-01-18.
Next steps
- Run an FDA pathway report with predicate devices for product code QDI
- Run a recall and safety report across every QDI manufacturer
- Watch product code QDI 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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