Immunoassay, Insulin-Like Growth Factor Binding Protein-1
The Immunoassay, Insulin-Like Growth Factor Binding Protein-1 (product code OAM) is a qualitative immunochromatographic test used by healthcare professionals for the detection of insulin-like growth factor binding protein-1 (IGFBP-1) in cervicovaginal secretions, intended to help diagnose the rupture of fetal membranes in pregnant women by detecting the presence of amniotic fluid. It is classified as FDA Class 1, regulated under 21 CFR 862.1550 within the Clinical Chemistry specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAM
- Device Class
- FDA class 1
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.