# Osmolality Of Tears
> **Product code: OND** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1540
## Classification
- **FDA Product Code:** OND
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1540
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OND)
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