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U.S. Department of Health and Human Services

Product Classification

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Device immunohistochemistry test, dna mismatch repair (mmr) protein assay
Regulation Description Immunohistochemistry reagents and kits.
Definition The DNA Mismatch Repair Protein Antibody is a qualitative immunohistochemical antibody intended for the assessment of mismatch repair (MMR) proteins in human clinical tissue specimens. The DNA Mismatch Repair Protein Antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Physical State The device includes a panel of monoclonal primary antibodies and accessory reagents, including secondary antibodies, buffers, substrates, and counterstains. The device may be intended for manual or automated staining methods.
Technical Method The test uses a panel of primary monoclonal antibody to detect the absence or presence of expressed antigen protein in fixed tissue specimens. Antibody-antigen complexes are visualized using an enzyme conjugated primary or secondary antibody to catalyze a color-producing reaction.
Target Area Formalin-fixed paraffin-embedded (FFPE) human clinical tissue specimens
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeQNH
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible