# Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
> **Product code: PKW** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** PKW
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** PA
- **Medical specialty:** Unknown
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens.  The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PKW)
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