DeviceClearance

Product code QKE— Clinical Chemistry

Proov Test

Classification name
Immunoassay, Pregnanediol Glucuronide, Over The Counter
Device class
Class 1
Regulation
21 CFR 862.1620
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation”

— U.S. Food and Drug Administration, device classification record for product code QKE under 21 CFR 862.1620, via openFDA

Market context for product code QKE

FDA has cleared 1 device under product code QKE, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QKE

Recent clearances under product code QKE

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