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- Subpart B—Biological StainsCFR Sub-Part
- HYQIron Chloride-Weigert1Product Code
- HYRLeuco-Patent Blue1Product Code
- HYSLight Green1Product Code
- HYTLuxol Fast Blue1Product Code
- HYWStain, Trichrome, Mallory'S1Product Code
- HYYMetanil Yellow1Product Code
- HYZMethenamine Silver1Product Code
- HZAMethyl Green1Product Code
- HZCMucicarmine1Product Code
- HZDMuller'S Colloidal Iron1Product Code
- HZENile Blue1Product Code
- HZFNuclear Fast Red1Product Code
- HZGOil Red O1Product Code
- HZHOrange G1Product Code
- HYHGold Chloride1Product Code
- HYIIodine, Grams1Product Code
- HYJHematoxylin1Product Code
- HYKHematoxylin Harris'S1Product Code
- HYLHematoxylin Mayer'S1Product Code
- HYOHematoxylin Weigert'S1Product Code
- GGHIron Stains1Product Code
- GHZSolution, Gugol Blue1Product Code
- HYBEosin Y1Product Code
- HYCFast Green1Product Code
- HYDFast Red Salt B1Product Code
- HYESolution, Fontanna Silver1Product Code
- HYFGiemsa Stain1Product Code
- HYGGlenner'S Stain1Product Code
- HZJStain, Papanicolau1Product Code
- HZLPhloxine B1Product Code
- HZMHematoxylin, Acid, Phosphotungstic1Product Code
- HZNPicro Methyl Blue1Product Code
- HZOStain, Ponceau1Product Code
- HZPPyronin1Product Code
- HZQRed-Violet Lb1Product Code
- HZRResorcin Fuchsin1Product Code
- HZSSafranin1Product Code
- HZTReagent, Schiff1Product Code
- HZXSilver Nitrate1Product Code
- HZYSirius Red1Product Code
- HZZSudan Black B1Product Code
- IAATitan Yellow1Product Code
- IABToluidine Blue1Product Code
- IACVan Gieson'S Stain1Product Code
- IADVan Gieson'S Picro-Fuchsin1Product Code
- IAEHematoxylin, Iron, Weigert'S1Product Code
- IAFWright'S Stain1Product Code
- ICCEosin B1Product Code
- ICDDarrow Red1Product Code
- ICFCrystal Violet For Histology1Product Code
- ICGCresyl Violet Acetate1Product Code
- ICHCongo Red1Product Code
- ICIHematoxylin, Chrome Alum1Product Code
- ICJCarbol Night Blue1Product Code
- ICLCarbol Fuchsin1Product Code
- ICMBrilliant Yellow1Product Code
- ICNBiebrich Scarlet1Product Code
- ICOBest'S Carmine1Product Code
- ICQAzure A1Product Code
- ICRAzocarmine B1Product Code
- ICSAzocarmine G1Product Code
- ICTAzan Counterstain1Product Code
- ICXAniline1Product Code
- ICYAcid, Aniline, Fuchsin1Product Code
- ICZAmmoniacal Silver Hydroxide Silver Nitrate1Product Code
- IDAAlcian Blue1Product Code
- IDBAldehyde Fuchsin1Product Code
- IDCAcridine Orange1Product Code
- IDDAlizarin Red1Product Code
- IDEAcid, Hematein1Product Code
- IDFAcid, Fuchsin1Product Code
- JCHEsterase1Product Code
- JCIAcid Phosphatase, Cytochemical1Product Code
- KFCMethylene Blue, Tissue Stain1Product Code
- KFDAniline Blue1Product Code
- KFENeutral Red1Product Code
- KJKAuramine O1Product Code
- KJLAzure C1Product Code
- KJMBismarck Brown Y1Product Code
- KJNBrilliant Cresyl Blue1Product Code
- KJOBrilliant Green1Product Code
- KJPCarmine1Product Code
- KJQChlorazol Black E1Product Code
- KJRErythrosin B1Product Code
- KJSEthyl Eosin1Product Code
- KJTIndigocarmine1Product Code
- KJWJanus Green B1Product Code
- KJXJenner Stain1Product Code
- KJYMalachite Green1Product Code
- KJZMartius Yellow1Product Code
- KKAMethyl Orange1Product Code
- KKBMethyl Violet 2b1Product Code
- KKCMethylene Violet1Product Code
- KKDNigrosin1Product Code
- KKEOrange Ii1Product Code
- KKFOrcein1Product Code
- KKGProtargol S1Product Code
- KKHTablet, Resazurin1Product Code
- KKIRose Bengal1Product Code
- KKJSudan Iii1Product Code
- KKKSudan Iv1Product Code
- KKLThionin1Product Code
- KKMMethylene Blue Thiocyanate1Product Code
- KKPSolution, Silver Carbonate1Product Code
- KKQSodium Periodate1Product Code
- KKRPotassium Periodate1Product Code
- KKSAcid, Periodic1Product Code
- KKTHematoxylin, Ehrlich'S1Product Code
- KKWBasic Fuchsin1Product Code
- KQCStains, Hematology1Product Code
- LEDStains, Chemical Solution1Product Code
- LEEStains, Dye Solution1Product Code
- LEFStains, Dye Powder1Product Code
- LGYTrypan Blue1Product Code
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor2Product Code
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor2Product Code
- NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer2Product Code
- NJTImmunohistochemistry Reagents And Kits1Product Code
- NJWControl Material, Her-2/Neu, Immunohistochemistry2Product Code
- NKFImmunohistochemistry Antibody Assay, C-Kit3Product Code
- NOTMicroscope, Automated, Image Analysis, Operator Intervention2Product Code
- NQFImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor3Product Code
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity2Product Code
- NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells1Product Code
- OEOAutomated Digital Image Manual Interpretation Microscope2Product Code
- PDOEarly Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization2Product Code
- PFGDna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders2Product Code
- QNHImmunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay3Product Code
- PZJLynch Syndrome Test System2Product Code
- PRBCervical Intraepithelial Neoplasia (Cin) Test System2Product Code
- QULImmunohistochemistry Assay, Antibody, Folr13Product Code
- QZJImmunohistochemistry Assay, Antibody, Claudin 183Product Code
- SBLImmunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A43Product Code
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
- Page Type
- Product Code
- 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
- Submission Type
- PMA
- Device Classification
- Class 3
- Regulation Number
- 864.1860
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.1860 Immunohistochemistry reagents and kits
§ 864.1860 Immunohistochemistry reagents and kits.
(a) 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.
(b) Classification of immunohistochemistry devices. (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. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.
(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.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c) Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.
[63 FR 30142, June 3, 1998]