FDA product code QQB: Prognostic Test For Assessment Of Liver Related Disease Progression

QQB is the FDA product code for prognostic test for assessment of liver related disease progression. It is a Class II device, regulated under 21 CFR 862.1622 and reviewed by the Clinical Chemistry panel. Devices under QQB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.

Classification

Recalls for QQB devices

openFDA lists no recalls for product code QQB.

Frequently asked questions

What is FDA product code QQB?

QQB is the FDA product code for prognostic test for assessment of liver related disease progression. It is a Class II device, regulated under 21 CFR 862.1622 and reviewed by the Clinical Chemistry panel.

What device class is QQB?

Class II, regulation 21 CFR 862.1622. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QQB
• Run a recall and safety report across every QQB manufacturer
• Watch product code QQB 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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