| Device |
immunohistochemistry assay, antibody, claudin 18 |
| Regulation Description |
Immunohistochemistry reagents and kits. |
| Definition |
The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. |
| Physical State |
The device includes a monoclonal primary antibody 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 primary monoclonal antibody to detect the 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 |
Human clinical tissue specimens |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Pathology |
|---|
| Product Code | QZJ |
|---|
| 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
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
