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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namesalivary estriol test
Generic Namesalivary estriol test
1240 elko drive
sunnyvale, CA 94089
PMA NumberP970032
Date Received07/16/1997
Decision Date04/29/1998
Withdrawal Date 08/23/2016
Product Code
Docket Number 99M-2168
Notice Date 07/13/1999
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the SalEst(TM). This device is intended to detect and measure by enzyme-linked immunoabsorbant assay (ELISA) technology the level of salivary estriol in pregnant women. The device is indicated for use as an aid in identifying risk of spontaneous preterm labor and delivery in singleton pregnancies. The device can be used every 1 to 2 weeks from gestational ages 22 to 36 weeks. The test should be used as a component of the clinician's assessment of risk for preterm labor and delivery.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001