FDA product code SEA: Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

SEA is the FDA product code for test for detection of microorganism(s) causing sexually transmitted infections performed by lay users. It is a Class II device, regulated under 21 CFR 866.3386 and reviewed by the Microbiology panel. Devices under SEA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.

Classification

Recalls for SEA devices

openFDA lists no recalls for product code SEA.

Frequently asked questions

What is FDA product code SEA?

SEA is the FDA product code for test for detection of microorganism(s) causing sexually transmitted infections performed by lay users. It is a Class II device, regulated under 21 CFR 866.3386 and reviewed by the Microbiology panel.

What device class is SEA?

Class II, regulation 21 CFR 866.3386. Typical premarket route: 510(k).

Next steps

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