# Autonomous Extracorporeal Blood Leak Detector/Alarm
> **Product code: ODX** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5820
## Classification
- **FDA Product Code:** ODX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5820
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff.  The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ODX)
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