SALEST TM SYSTEM
FDA premarket approval P970032 · decided 1998-04-29
Approval details
- PMA number
- P970032
- Trade name
- SALEST TM SYSTEM
- Generic name
- salivary estriol test
- Applicant
- Hologic, Inc.
- Date received
- 1997-07-16
- Decision date
- 1998-04-29
- Days to decision
- 287 days
- Decision code
- APWD
- Product code
- PEJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- Yes
- Location
- Sunnyvale, CA
- 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.
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