FDA product code QMI: Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
QMI is the FDA product code for nucleic acid amplification test for the quantitation of bk virus (bk) dna. It is a Class II device, regulated under 21 CFR 866.3183 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QMI, 1 in the last five years, from 2 different applicants. The average 510(k) review took 146 days (median 146); 266 days on average over the last three years.
Definition
An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna |
| Device class | Class II |
| Regulation | 21 CFR 866.3183 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QMI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 27 |
| 2025 | 1 | 266 |
Compare with all 510(k) review times · Search every QMI clearance
Top QMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 2025-03-24 |
| Roche Molecular Systems, Inc. | 1 | 2020-09-02 |
Most recent QMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241921 | Abbott Molecular, Inc. | Alinity m BKV | 2025-03-24 | 266 |
| K202215 | Roche Molecular Systems, Inc. | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | 2020-09-02 | 27 |
Recalls for QMI devices
openFDA lists no recalls for product code QMI.
Frequently asked questions
What is FDA product code QMI?
QMI is the FDA product code for nucleic acid amplification test for the quantitation of bk virus (bk) dna. It is a Class II device, regulated under 21 CFR 866.3183 and reviewed by the Microbiology panel.
What device class is QMI?
Class II, regulation 21 CFR 866.3183. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMI?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most QMI clearances?
Abbott Molecular, Inc. (1); Roche Molecular Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMI
- Run a recall and safety report across every QMI manufacturer
- Watch product code QMI 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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