# Immunoassay, Insulin-Like Growth Factor Binding Protein-1
> **Product code: OAM** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550
## Classification
- **FDA Product Code:** OAM
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1550
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OAM)
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