21 CFR 864.1860 — Kit, Assay, Progesterone Receptor
Hematology (HE) · Part 864 Subpart B—Biological Stains · § 864.1860
Identification
Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.
Classification Rationale
(1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. (2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). (3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LPI | Kit, Assay, Progesterone Receptor | 3 | 4 | |
| LPJ | Kit, Assay, Estrogen Receptor | 3 | 4 | |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 2 | 13 | 3rd Party |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 2 | 12 | 3rd Party |
| NBK | System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer | 2 | 1 | |
| NJT | Immunohistochemistry Reagents And Kits | 1 | 0 | |
| NJW | Control Material, Her-2/Neu, Immunohistochemistry | 2 | 2 | 3rd Party |
| NKF | Immunohistochemistry Antibody Assay, C-Kit | 3 | 2 | |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 2 | 12 | |
| NQF | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor | 3 | 1 | |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 2 | 15 | |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells | 1 | 1 | |
| OEO | Automated Digital Image Manual Interpretation Microscope | 2 | 6 | SaMD |
| QKF | Immunocytochemistry Assay, P16/Ki-67 | 3 | 1 | |
| QNH | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | 3 | 3 | |
| QUL | Immunohistochemistry Assay, Antibody, Folr1 | 3 | 1 | |
| QZJ | Immunohistochemistry Assay, Antibody, Claudin 18 | 3 | 1 | |
| SBL | Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 | 3 | 1 | |
| SER | Immunohistochemistry Assay, Antibody, Met | 3 | 1 |
Special Controls
LPI — Kit, Assay, Progesterone Receptor
(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
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