FDA product code OAW: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

OAW is the FDA product code for cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma. It is a HDE device, reviewed by the Immunology panel. Devices under OAW reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OAW devices.

Definition

A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.

Classification

Recalls for OAW devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-07-29.

Frequently asked questions

What is FDA product code OAW?

OAW is the FDA product code for cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma. It is a HDE device, reviewed by the Immunology panel.

What device class is OAW?

HDE. Typical premarket route: Unclassified.

Have OAW devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-07-29.

Next steps

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