Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3385](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3385) → QYA — System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

# 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_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYA

## 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](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3385)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYA/K243410.md) | simpli-COLLECT STI Test | Abbott Molecular | Jan 30, 2025 | SESE |
| [DEN200070](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYA/DEN200070.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYA)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com