FDA product code QBB: Placental Alpha Microglobulin-1 Immunoassay
QBB is the FDA product code for placental alpha microglobulin-1 immunoassay. It is a Class III device, reviewed by the Clinical Toxicology panel. Devices under QBB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.
Classification
| Field | Value |
|---|---|
| Device name | Placental Alpha Microglobulin-1 Immunoassay |
| Device class | Class III |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QBB devices
openFDA lists no recalls for product code QBB.
Frequently asked questions
What is FDA product code QBB?
QBB is the FDA product code for placental alpha microglobulin-1 immunoassay. It is a Class III device, reviewed by the Clinical Toxicology panel.
What device class is QBB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QBB
- Run a recall and safety report across every QBB manufacturer
- Watch product code QBB 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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