DeviceClearance

Product code QYA— Microbiology

Simple 2 Test

Classification name
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
Device class
Class 2
Regulation
21 CFR 866.3385
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.”

— U.S. Food and Drug Administration, device classification record for product code QYA under 21 CFR 866.3385, via openFDA

Market context for product code QYA

FDA has cleared 2 devices under product code QYA between 2023 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QYA

Recent clearances under product code QYA

Data sourced from openFDA. This site is unofficial and independent of the FDA.