FDA product code QTM: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.
QTM is the FDA product code for assayed external control material for microbiology nucleic acid amplification (nat) assays for blood donor screening.. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel. Devices under QTM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.
Classification
| Field | Value |
|---|---|
| Device name | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. |
| Device class | Class II |
| Regulation | 21 CFR 866.3920 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QTM devices
openFDA lists no recalls for product code QTM.
Frequently asked questions
What is FDA product code QTM?
QTM is the FDA product code for assayed external control material for microbiology nucleic acid amplification (nat) assays for blood donor screening.. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel.
What device class is QTM?
Class II, regulation 21 CFR 866.3920. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QTM
- Run a recall and safety report across every QTM manufacturer
- Watch product code QTM 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times