# Immunoglobulin M Kappa Heavy And Light Chain Combined
> **Product code: PDE** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5510
## Classification
- **FDA Product Code:** PDE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5510
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Intended for the in-vitro quantification of IgM kappa concentration in human serum.  The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.

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