OAM — Immunoassay, Insulin-Like Growth Factor Binding Protein-1 Class I
FDA product code OAM covers "Immunoassay, Insulin-Like Growth Factor Binding Protein-1", a Class I medical device regulated under 21 CFR 862.1550. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAM
- Device Class
- Class I
- Regulation Number
- 862.1550
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.