QYA · System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
Microbiology · 21 CFR 866.3385 · Class 2
Overview
| Product Code | QYA |
|---|---|
| Device Name | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home |
| Regulation | 21 CFR 866.3385 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243410 | simpli-COLLECT STI Test | Abbott Molecular | Jan 30, 2025 | SESE |
| DEN200070 | Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | Nov 15, 2023 | DENG |
Top Applicants
- Abbott Molecular — 1 clearance
- Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) — 1 clearance
