Product Code: SEA FDA class 2 21 CFR 866.3386

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Microbiology

A test for detection of microorganisms causing sexually transmitted infections performed by lay users is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral sexually transmitted infection-causing microorganisms in clinical specimens collected in home settings or similar environments, intended for prescription or over-the-counter use. It is classified as FDA Class II (510(k) required) under regulation 866.3386 in the Microbiology specialty, with product code SEA. The device is not an implant and does not support life-sustaining functions.

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510(k)s

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Basic Information

Product Code: SEA
Device Class: FDA class 2
Regulation Number: 866.3386
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.