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U.S. Department of Health and Human Services

Product Classification

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Device cervical intraepithelial neoplasia (cin) test system
Regulation Description Cervical intraepithelial neoplasia (CIN) test system.
Definition The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Physical State The device may include a primary antibody and accessory reagents or other detection system.
Technical Method The test uses a primary antibody, specific reagents or methods to detect p16INK4a protein in human clinical specimens. May include antibody-antigen protein complexes, which are visualized using an enzyme conjugated antibody or other detection systems or methods.
Target Area Human clinical specimens
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodePRB
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.1865
Device Class 2
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