Title 21

PART 864

Part 864 - Hematology And Pathology Devices

PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Editorial Note:Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.19.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.19.1.1.1SECTION 864.1
   864.1 Scope.
21:8.0.1.1.19.1.1.2SECTION 864.3
   864.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.19.1.1.3SECTION 864.9
   864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.19.2SUBPART B
Subpart B - Biological Stains
21:8.0.1.1.19.2.1.1SECTION 864.1850
   864.1850 Dye and chemical solution stains.
21:8.0.1.1.19.2.1.2SECTION 864.1860
   864.1860 Immunohistochemistry reagents and kits.
21:8.0.1.1.19.2.1.3SECTION 864.1865
   864.1865 Cervical intraepithelial neoplasia (CIN) test system.
21:8.0.1.1.19.2.1.4SECTION 864.1866
   864.1866 Lynch syndrome test systems.
21:8.0.1.1.19.2.1.5SECTION 864.1870
   864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
21:8.0.1.1.19.3SUBPART C
Subpart C - Cell And Tissue Culture Products
21:8.0.1.1.19.3.1.1SECTION 864.2220
   864.2220 Synthetic cell and tissue culture media and components.
21:8.0.1.1.19.3.1.2SECTION 864.2240
   864.2240 Cell and tissue culture supplies and equipment.
21:8.0.1.1.19.3.1.3SECTION 864.2260
   864.2260 Chromosome culture kit.
21:8.0.1.1.19.3.1.4SECTION 864.2280
   864.2280 Cultured animal and human cells.
21:8.0.1.1.19.3.1.5SECTION 864.2360
   864.2360 Mycoplasma detection media and components.
21:8.0.1.1.19.3.1.6SECTION 864.2800
   864.2800 Animal and human sera.
21:8.0.1.1.19.3.1.7SECTION 864.2875
   864.2875 Balanced salt solutions or formulations.
21:8.0.1.1.19.4SUBPART D
Subpart D - Pathology Instrumentation and Accessories
21:8.0.1.1.19.4.1.1SECTION 864.3010
   864.3010 Tissue processing equipment.
21:8.0.1.1.19.4.1.2SECTION 864.3250
   864.3250 Specimen transport and storage container.
21:8.0.1.1.19.4.1.3SECTION 864.3260
   864.3260 OTC test sample collection systems for drugs of abuse testing.
21:8.0.1.1.19.4.1.4SECTION 864.3300
   864.3300 Cytocentrifuge.
21:8.0.1.1.19.4.1.5SECTION 864.3400
   864.3400 Device for sealing microsections.
21:8.0.1.1.19.4.1.6SECTION 864.3600
   864.3600 Microscopes and accessories.
21:8.0.1.1.19.4.1.7SECTION 864.3700
   864.3700 Whole slide imaging system.
21:8.0.1.1.19.4.1.8SECTION 864.3800
   864.3800 Automated slide stainer.
21:8.0.1.1.19.4.1.9SECTION 864.3875
   864.3875 Automated tissue processor.
21:8.0.1.1.19.5SUBPART E
Subpart E - Specimen Preparation Reagents
21:8.0.1.1.19.5.1.1SECTION 864.4010
   864.4010 General purpose reagent.
21:8.0.1.1.19.5.1.2SECTION 864.4020
   864.4020 Analyte specific reagents.
21:8.0.1.1.19.5.1.3SECTION 864.4400
   864.4400 Enzyme preparations.
21:8.0.1.1.19.6SUBPART F
Subpart F - Automated and Semi-Automated Hematology Devices
21:8.0.1.1.19.6.1.1SECTION 864.5200
   864.5200 Automated cell counter.
21:8.0.1.1.19.6.1.2SECTION 864.5220
   864.5220 Automated differential cell counter.
21:8.0.1.1.19.6.1.3SECTION 864.5240
   864.5240 Automated blood cell diluting apparatus.
21:8.0.1.1.19.6.1.4SECTION 864.5260
   864.5260 Automated cell-locating device.
21:8.0.1.1.19.6.1.5SECTION 864.5300
   864.5300 Red cell indices device.
21:8.0.1.1.19.6.1.6SECTION 864.5350
   864.5350 Microsedimentation centrifuge.
21:8.0.1.1.19.6.1.7SECTION 864.5400
   864.5400 Coagulation instrument.
21:8.0.1.1.19.6.1.8SECTION 864.5425
   864.5425 Multipurpose system for in vitro coagulation studies.
21:8.0.1.1.19.6.1.9SECTION 864.5600
   864.5600 Automated hematocrit instrument.
21:8.0.1.1.19.6.1.10SECTION 864.5620
   864.5620 Automated hemoglobin system.
21:8.0.1.1.19.6.1.11SECTION 864.5680
   864.5680 Automated heparin analyzer.
21:8.0.1.1.19.6.1.12SECTION 864.5700
   864.5700 Automated platelet aggregation system.
21:8.0.1.1.19.6.1.13SECTION 864.5800
   864.5800 Automated sedimentation rate device.
21:8.0.1.1.19.6.1.14SECTION 864.5850
   864.5850 Automated slide spinner.
21:8.0.1.1.19.6.1.15SECTION 864.5950
   864.5950 Blood volume measuring device.
21:8.0.1.1.19.7SUBPART G
Subpart G - Manual Hematology Devices
21:8.0.1.1.19.7.1.1SECTION 864.6100
   864.6100 Bleeding time device.
21:8.0.1.1.19.7.1.2SECTION 864.6150
   864.6150 Capillary blood collection tube.
21:8.0.1.1.19.7.1.3SECTION 864.6160
   864.6160 Manual blood cell counting device.
21:8.0.1.1.19.7.1.4SECTION 864.6400
   864.6400 Hematocrit measuring device.
21:8.0.1.1.19.7.1.5SECTION 864.6550
   864.6550 Occult blood test.
21:8.0.1.1.19.7.1.6SECTION 864.6600
   864.6600 Osmotic fragility test.
21:8.0.1.1.19.7.1.7SECTION 864.6650
   864.6650 Platelet adhesion test.
21:8.0.1.1.19.7.1.8SECTION 864.6675
   864.6675 Platelet aggregometer.
21:8.0.1.1.19.7.1.9SECTION 864.6700
   864.6700 Erythrocyte sedimentation rate test.
21:8.0.1.1.19.8SUBPART H
Subpart H - Hematology Kits and Packages
21:8.0.1.1.19.8.1.1SECTION 864.7010
   864.7010 Flow cytometric test system for hematopoietic neoplasms.
21:8.0.1.1.19.8.1.2SECTION 864.7040
   864.7040 Adenosine triphosphate release assay.
21:8.0.1.1.19.8.1.3SECTION 864.7060
   864.7060 Antithrombin III assay.
21:8.0.1.1.19.8.1.4SECTION 864.7100
   864.7100 Red blood cell enzyme assay.
21:8.0.1.1.19.8.1.5SECTION 864.7140
   864.7140 Activated whole blood clotting time tests.
21:8.0.1.1.19.8.1.6SECTION 864.7250
   864.7250 Erythropoietin assay.
21:8.0.1.1.19.8.1.7SECTION 864.7275
   864.7275 Euglobulin lysis time tests.
21:8.0.1.1.19.8.1.8SECTION 864.7280
   864.7280 Factor V Leiden DNA mutation detection systems.
21:8.0.1.1.19.8.1.9SECTION 864.7290
   864.7290 Factor deficiency test.
21:8.0.1.1.19.8.1.10SECTION 864.7300
   864.7300 Fibrin monomer paracoagulation test.
21:8.0.1.1.19.8.1.11SECTION 864.7320
   864.7320 Fibrinogen/fibrin degradation products assay.
21:8.0.1.1.19.8.1.12SECTION 864.7340
   864.7340 Fibrinogen determination system.
21:8.0.1.1.19.8.1.13SECTION 864.7360
   864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
21:8.0.1.1.19.8.1.14SECTION 864.7375
   864.7375 Glutathione reductase assay.
21:8.0.1.1.19.8.1.15SECTION 864.7400
   864.7400 Hemoglobin A2 assay.
21:8.0.1.1.19.8.1.16SECTION 864.7415
   864.7415 Abnormal hemoglobin assay.
21:8.0.1.1.19.8.1.17SECTION 864.7425
   864.7425 Carboxyhemoglobin assay.
21:8.0.1.1.19.8.1.18SECTION 864.7440
   864.7440 Electrophoretic hemoglobin analysis system.
21:8.0.1.1.19.8.1.19SECTION 864.7455
   864.7455 Fetal hemoglobin assay.
21:8.0.1.1.19.8.1.20SECTION 864.7470
   864.7470 Glycosylated hemoglobin assay.
21:8.0.1.1.19.8.1.21SECTION 864.7490
   864.7490 Sulfhemoglobin assay.
21:8.0.1.1.19.8.1.22SECTION 864.7500
   864.7500 Whole blood hemoglobin assays.
21:8.0.1.1.19.8.1.23SECTION 864.7525
   864.7525 Heparin assay.
21:8.0.1.1.19.8.1.24SECTION 864.7660
   864.7660 Leukocyte alkaline phosphatase test.
21:8.0.1.1.19.8.1.25SECTION 864.7675
   864.7675 Leukocyte peroxidase test.
21:8.0.1.1.19.8.1.26SECTION 864.7695
   864.7695 Platelet factor 4 radioimmunoassay.
21:8.0.1.1.19.8.1.27SECTION 864.7720
   864.7720 Prothrombin consumption test.
21:8.0.1.1.19.8.1.28SECTION 864.7735
   864.7735 Prothrombin-proconvertin test and thrombotest.
21:8.0.1.1.19.8.1.29SECTION 864.7750
   864.7750 Prothrombin time test.
21:8.0.1.1.19.8.1.30SECTION 864.7825
   864.7825 Sickle cell test.
21:8.0.1.1.19.8.1.31SECTION 864.7875
   864.7875 Thrombin time test.
21:8.0.1.1.19.8.1.32SECTION 864.7900
   864.7900 Thromboplastin generation test.
21:8.0.1.1.19.8.1.33SECTION 864.7925
   864.7925 Partial thromboplastin time tests.
21:8.0.1.1.19.9SUBPART I
Subpart I - Hematology Reagents
21:8.0.1.1.19.9.1.1SECTION 864.8100
   864.8100 Bothrops atrox reagent.
21:8.0.1.1.19.9.1.2SECTION 864.8150
   864.8150 Calibrator for cell indices.
21:8.0.1.1.19.9.1.3SECTION 864.8165
   864.8165 Calibrator for hemoglobin or hematocrit measurement.
21:8.0.1.1.19.9.1.4SECTION 864.8175
   864.8175 Calibrator for platelet counting.
21:8.0.1.1.19.9.1.5SECTION 864.8185
   864.8185 Calibrator for red cell and white cell counting.
21:8.0.1.1.19.9.1.6SECTION 864.8200
   864.8200 Blood cell diluent.
21:8.0.1.1.19.9.1.7SECTION 864.8500
   864.8500 Lymphocyte separation medium.
21:8.0.1.1.19.9.1.8SECTION 864.8540
   864.8540 Red cell lysing reagent.
21:8.0.1.1.19.9.1.9SECTION 864.8625
   864.8625 Hematology quality control mixture.
21:8.0.1.1.19.9.1.10SECTION 864.8950
   864.8950 Russell viper venom reagent.
21:8.0.1.1.19.10SUBPART J
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
21:8.0.1.1.19.10.1.1SECTION 864.9050
   864.9050 Blood bank supplies.
21:8.0.1.1.19.10.1.2SECTION 864.9100
   864.9100 Empty container for the collection and processing of blood and blood components.
21:8.0.1.1.19.10.1.3SECTION 864.9125
   864.9125 Vacuum-assisted blood collection system.
21:8.0.1.1.19.10.1.4SECTION 864.9145
   864.9145 Processing system for frozen blood.
21:8.0.1.1.19.10.1.5SECTION 864.9160
   864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
21:8.0.1.1.19.10.1.6SECTION 864.9165
   864.9165 Blood establishment computer software and accessories.
21:8.0.1.1.19.10.1.7SECTION 864.9175
   864.9175 Automated blood grouping and antibody test system.
21:8.0.1.1.19.10.1.8SECTION 864.9185
   864.9185 Blood grouping view box.
21:8.0.1.1.19.10.1.9SECTION 864.9195
   864.9195 Blood mixing devices and blood weighing devices.
21:8.0.1.1.19.10.1.10SECTION 864.9205
   864.9205 Blood and plasma warming device.
21:8.0.1.1.19.10.1.11SECTION 864.9225
   864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
21:8.0.1.1.19.10.1.12SECTION 864.9245
   864.9245 Automated blood cell separator.
21:8.0.1.1.19.10.1.13SECTION 864.9275
   864.9275 Blood bank centrifuge for in vitro diagnostic use.
21:8.0.1.1.19.10.1.14SECTION 864.9285
   864.9285 Automated cell-washing centrifuge for immuno-hematology.
21:8.0.1.1.19.10.1.15SECTION 864.9300
   864.9300 Automated Coombs test systems.
21:8.0.1.1.19.10.1.16SECTION 864.9320
   864.9320 Copper sulfate solution for specific gravity determinations.
21:8.0.1.1.19.10.1.17SECTION 864.9400
   864.9400 Stabilized enzyme solution.
21:8.0.1.1.19.10.1.18SECTION 864.9550
   864.9550 Lectins and protectins.
21:8.0.1.1.19.10.1.19SECTION 864.9575
   864.9575 Environmental chamber for storage of platelet concentrate.
21:8.0.1.1.19.10.1.20SECTION 864.9600
   864.9600 Potentiating media for in vitro diagnostic use.
21:8.0.1.1.19.10.1.21SECTION 864.9650
   864.9650 Quality control kit for blood banking reagents.
21:8.0.1.1.19.10.1.22SECTION 864.9700
   864.9700 Blood storage refrigerator and blood storage freezer.
21:8.0.1.1.19.10.1.23SECTION 864.9750
   864.9750 Heat-sealing device.
21:8.0.1.1.19.10.1.24SECTION 864.9875
   864.9875 Transfer set.
21:8.0.1.1.19.11SUBPART K
Subpart K - Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
21:8.0.1.1.19.11.1.1SECTION 864.9900
   864.9900 Cord blood processing system and storage container.