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U.S. Department of Health and Human Services

Product Classification
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Device chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer
Definition This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist.
Physical State brightfield microscopy
Technical Method Chromogenic In Situ Hybridization
Target Area breast carcinoma tissue sections
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodeNYQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.1890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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