FDA product code MWA: System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

MWA is the FDA product code for system, nucleic acid amplification, mycobacterium tuberculosis complex. It is a Class II device, regulated under 21 CFR 866.3372 and reviewed by the Microbiology panel. Devices under MWA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 2 recalls for MWA devices.

Definition

intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

Classification

Recalls for MWA devices

2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-28.

Frequently asked questions

What is FDA product code MWA?

MWA is the FDA product code for system, nucleic acid amplification, mycobacterium tuberculosis complex. It is a Class II device, regulated under 21 CFR 866.3372 and reviewed by the Microbiology panel.

What device class is MWA?

Class II, regulation 21 CFR 866.3372. Typical premarket route: 510(k).

Have MWA devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2012-11-28.

Next steps

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