# Antigen, Cartilage Oligomeric Matrix Protein (Comp)
> **Product code: NPH** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5775
## Classification
- **FDA Product Code:** NPH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5775
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NPH)
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