Title 21, Part 864 — Hematology and Pathology Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Dye and chemical solution stains.

Immunohistochemistry reagents and kits.

Cervical intraepithelial neoplasia (CIN) test system.

Lynch syndrome test systems.

Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.

Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.

Synthetic cell and tissue culture media and components.

Cell and tissue culture supplies and equipment.

Chromosome culture kit.

Cultured animal and human cells.

Mycoplasma detection media and components.

Animal and human sera.

Balanced salt solutions or formulations.

Tissue processing equipment.

Specimen transport and storage container.

OTC test sample collection systems for drugs of abuse testing.

Cytocentrifuge.

Device for sealing microsections.

Microscopes and accessories.

Whole slide imaging system.

Software algorithm device to assist users in digital pathology.

Automated slide stainer.

Automated tissue processor.

General purpose reagent.

Analyte specific reagents.

Enzyme preparations.

Automated cell counter.

Automated differential cell counter.

Automated blood cell diluting apparatus.

Automated cell-locating device.

Red cell indices device.

Microsedimentation centrifuge.

Coagulation instrument.

Multipurpose system for in vitro coagulation studies.

Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.

Automated hematocrit instrument.

Automated hemoglobin system.

Automated heparin analyzer.

Automated platelet aggregation system.

Automated sedimentation rate device.

Automated slide spinner.

Blood volume measuring device.

Bleeding time device.

Capillary blood collection tube.

Manual blood cell counting device.

Hematocrit measuring device.

Occult blood test.

Osmotic fragility test.

Platelet adhesion test.

Platelet aggregometer.

Erythrocyte sedimentation rate test.

Flow cytometric test system for hematopoietic neoplasms.

Adenosine triphosphate release assay.

Antithrombin III assay.

Red blood cell enzyme assay.

Activated whole blood clotting time tests.

Erythropoietin assay.

Euglobulin lysis time tests.

Factor V Leiden DNA mutation detection systems.

Factor deficiency test.

Heparin and direct oral factor Xa inhibitor drug test system.

Fibrin monomer paracoagulation test.

Fibrinogen/fibrin degradation products assay.

Fibrinogen determination system.

Erythrocytic glucose-6-phosphate dehydrogenase assay.

Glutathione reductase assay.

Hemoglobin A assay.

Abnormal hemoglobin assay.

Carboxyhemoglobin assay.

Electrophoretic hemoglobin analysis system.

Fetal hemoglobin assay.

Glycosylated hemoglobin assay.

Sulfhemoglobin assay.

Whole blood hemoglobin assays.

Heparin assay.

Leukocyte alkaline phosphatase test.

Leukocyte peroxidase test.

Platelet factor 4 radioimmunoassay.

Prothrombin consumption test.

Prothrombin-proconvertin test and thrombotest.

Prothrombin time test.

Sickle cell test.

Thrombin time test.

Thromboplastin generation test.

Partial thromboplastin time tests.

Bothrops atrox reagent.

Calibrator for cell indices.

Calibrator for hemoglobin or hematocrit measurement.

Calibrator for platelet counting.

Calibrator for red cell and white cell counting.

Blood cell diluent.

Lymphocyte separation medium.

Red cell lysing reagent.

Hematology quality control mixture.

Russell viper venom reagent.

Blood bank supplies.

Empty container for the collection and processing of blood and blood components.

Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.

Vacuum-assisted blood collection system.

Processing system for frozen blood.

Blood group substances of nonhuman origin for in vitro diagnostic use.

Blood establishment computer software and accessories.

Automated blood grouping and antibody test system.

Blood grouping view box.

Blood mixing devices and blood weighing devices.

Blood and plasma warming device.

Cell-freezing apparatus and reagents for in vitro diagnostic use.

Automated blood cell separator.

Blood bank centrifuge for in vitro diagnostic use.

Automated cell-washing centrifuge for immuno-hematology.

Automated Coombs test systems.

Copper sulfate solution for specific gravity determinations.

Stabilized enzyme solution.

Lectins and protectins.

Environmental chamber for storage of platelet concentrate.

Potentiating media for in vitro diagnostic use.

Quality control kit for blood banking reagents.

Blood storage refrigerator and blood storage freezer.

Heat-sealing device.

Transfer set.

Cord blood processing system and storage container.