§ 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system. (a) Identification. An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities. (b) Classification. Class I. The device is exempt from the premarket notifica tion procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994] §866.5550 Immunoglobulin (light chain specific) immunological test system. (a) Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). immunological test system. (a) Identification. A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels. (b) Classification. Class I (general controls). (b) Classification. Class II (performance standards). § 866.5620 Alpha-2-macroglobulin immunological test system. Identification. An alpha-2 (a) macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. (b) Classification. Class II (performance standards). § 866.5630 Beta-2-microglobulin immunological test system. (a) Identification. A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease. (b) Classification. Class II (performance standards). or § 866.5700 Whole human plasma serum immunological test system. (a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994] § 866.5715 Plasminogen immunological test system. (a) Identification. A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a bloodclotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (bloodclotting) disorders. immunological test system. (a) Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid. (b) Classification. Class II (performance standards). § 866.5880 Transferrin immunological test system. (a) Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. (b) Classification. Class II (performance standards). § 866.5890 Inter-alpha trypsin inhibitor immunological test system. (a) Identification. An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the interalpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation. (b) Classification. Class I (general controls). [47 FR 50823, Nov. 9, 1982. as amended at 53 FR 11253, Apr. 6, 1988] 868.1640 Helium gas analyzer. Subpart G-Tumor Associated Antigen immunological Test Systems 868.1670 868.1690 antigen §866.6010 Tumor-associated immunological test system. (a) Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease. (b) Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards. [62 FR 66005, Dec. 17, 1997] Neon gas analyzer. Nitrogen gas analyzer. 868.1700 Nitrous oxide gas analyzer. 868.1720 Oxygen gas analyzer. 868.1730 Oxygen uptake computer. 868.1750 Pressure plethysmograph. 868.1760 Volume plethysmograph. 868.1780 Inspiratory airway pressure meter. 868.1800 Rhinoanemometer. 868.1840 Diagnostic spirometer. 868.1850 Monitoring spirometer. 868.1860 Peak-flow meter for spirometry. 868.1870 Gas volume calibrator. 868.1880 Pulmonary-function lator. 868.1890 Predictive value calculator. data calcu pulmonary-function 868.2340 Compensated meter. thorpe tube flow 868.2350 Gas calibration flowmeter. 868.2375 Breathing frequency monitor. 868.2450 Lung water monitor. 868.2480 Cutaneous carbon dioxide (PCCO2) monitor. 868.2500 Cutaneous oxygen monitor. 868.2550 Pneumotachometer. 868.2600 Airway pressure monitor. 868.2610 Gas pressure gauge. 868.2620 Gas pressure calibrator. 868.2700 Pressure regulator. 868.2775 Electrical peripheral nerve stimulator. 868.2875 Differential pressure transducer. 868.2885 Gas flow transducer. 868.2900 Gas pressure transducer. Subparts D-E [Reserved] Subpart F-Therapeutic Devices 868.5090 Emergency airway needle. 868.5100 Nasopharyngeal airway. 868.5110 Oropharyngeal airway. 868.5120 868.1200 Indwelling blood oxygen partial pressure (Po2) analyzer. 868.5130 868.5140 Anesthesia conduction catheter. Anesthesia conduction needle. Gas machine for anesthesia or anal 868.5170 Laryngotracheal topical anesthesia applicator. |