510(k) K061886
K061886 is an FDA 510(k) premarket notification submitted by Medix Biochemica for the device "ACTIM PROM AND CONTROLS". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code OAM (Immunoassay, Insulin-Like Growth Factor Binding Protein-1), a Class I device regulated under 21 CFR 862.1550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2007
- Date Received
- July 3, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay, Insulin-Like Growth Factor Binding Protein-1
- Device Class
- Class I
- Regulation Number
- 862.1550
- Review Panel
- CH
- Submission Type
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.