# KIT D816V Assay (ARUP Laboratories)

Source: https://onco.cc/drugs/arup-kit-d816v/  
OnCo record `arup-kit-d816v` (Device or software). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The bone marrow test the FDA lists with imatinib for aggressive systemic mastocytosis, approved as a humanitarian device for a rare disease.

## Summary

ARUP Laboratories' KIT D816V Assay was approved on 18 December 2015 under a Humanitarian Device Exemption (H140006), the route for devices used in rare conditions, and is listed by the FDA as the companion diagnostic for imatinib in aggressive systemic mastocytosis, tested on bone marrow.

## Fields

- Kind: Device or software
- Status: approved
- Last checked: 2026-11-03
- Also known as: KIT D816V Assay
- Tags: test
- Brand: KIT D816V Assay
- Modality: KIT D816V mutation detection test (bone marrow), Humanitarian Device Exemption
- Mechanism: Detects the KIT D816V mutation in bone marrow.
- Approvals: US 2015: Humanitarian Device Exemption; companion to imatinib in aggressive systemic mastocytosis (bone marrow)

## Sources

- FDA HDE H140006: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H140006
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- biomarkers: [KIT D816V](https://onco.cc/biomarkers/kit-d816v/)
- cancers: [Systemic mastocytosis](https://onco.cc/cancers/systemic-mastocytosis/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [KIT](https://onco.cc/targets/kit/)
- drugs: [Imatinib](https://onco.cc/drugs/imatinib/)
- companies: [ARUP Laboratories](https://onco.cc/companies/arup-laboratories/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/)

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