21 CFR 866.3385 — System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3385

Identification

The Simple 2 Test is an over-the-counter (OTC) in vitro diagnostic test intended for the detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens. The device consists of the Simple 2 Urine Home Collection Kit (Penile) and the Simple 2 Swab Home Collection Kit (Vaginal). Collected specimens are shipped to a CLIA-certified laboratory for testing using the Aptima Combo 2 Assay on the Panther System. The test is intended for consumers 18 years of age and older and includes a suitability questionnaire to determine if the test is appropriate for the individual.

Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.3385 as a system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens.

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