OIW

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

产品代码

OIW

器械名称

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.3100

FDA 专业组

Clinical Toxicology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician. The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。