DeviceClearance

Product code OAM— Clinical Chemistry

ACTIM PROM

Classification name
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Device class
Class 1
Regulation
21 CFR 862.1550
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification definition

“The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.”

— U.S. Food and Drug Administration, device classification record for product code OAM under 21 CFR 862.1550, via openFDA

Market context for product code OAM

FDA has cleared 2 devices under product code OAM between 2007 and 2014, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code OAM

Recent clearances under product code OAM

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