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$866.5700 Whole human plasma or 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.

(b) Classification. Class I (general controls). The device is exempt from the

premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§ 866.5735 Prothrombin immunological test system.

(a) Identification. A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. This exemption does not apply to multipurpose systems for in vitro coagulation studies classified under §864.5425 of this chapter or prothrombin time tests classified under § 864.7750 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§ 866.5750 Radioallergosorbent (RAST) immunological test system. Identification.

(a)

A

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(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

§ 866.5775 Rheumatoid factor immunological test system.

(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. (b) Classification. Class II (performance standards).

§ 866.5785 Anti-Saccharomyces

cerevisiae (S. cerevisiae) antibody (ASCA) test systems.

(a) Identification. The Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's dis

ease.

(b) Classification. Class II (special controls). The special control is FDA's "Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications."

[65 FR 70307, Nov. 22, 2000]

§ 866.5800 Seminal fluid (sperm) immunological test system.

(a) Identification. A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[54 FR 25047, June 12, 1989]

§ 866.5820 Systemic

lupus

erythematosus immunological test system.

(a) Identification. A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded

deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

(b) Classification. Class II (performance standards).

§ 866.5860 Total spinal fluid immunological test system.

(a) Identification. A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteins may aid in the diagnosis of multiple sclerosis and other diseases of the nervous system.

(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 61 FR 1119, Jan. 16, 1996]

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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 techby immunochemical niques 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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, 2000]

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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]

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868.2600 Airway pressure monitor. 868.2610 Gas pressure gauge.

868.2620 Gas pressure calibrator.

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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.

868.5115 Device to relieve acute upper air

way obstruction.

868.5120 Anesthesia conduction catheter.

Anesthesia conduction kit.

868.5130

Anesthesia conduction filter.

868.5140

868.5150

868.5160

gesia.

Anesthesia conduction needle.

Gas machine for anesthesia or anal

868.5165 Nitric oxide administration appa

ratus.

868.5170 Laryngotracheal topical anesthesia

applicator.

868.5180

Rocking bed.

868.5220 Blow bottle.

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868.5780 Tube introduction forceps.

868.5790 Tracheal tube stylet.

868.5795 Tracheal tube cleaning brush. 868.5800 Tracheostomy tube and tube cuff.

868.5810 Airway connector.

868.5820 Dental protector.

868.5830 Autotransfusion apparatus. 868.5860 Pressure tubing and accessories. 868.5870 Nonrebreathing valve.

868.5880 Anesthetic vaporizer. 868.5895 Continuous ventilator. 868.5905

Noncontinuous ventilator (IPPB). 868.5915 Manual emergency ventilator. 868.5925 Powered emergency ventilator. 868.5935 External negative pressure ventilator.

868.5955 Intermittent mandatory ventilation attachment.

868.5965 Positive end expiratory pressure breathing attachment.

868.5975 Ventilator tubing. 868.5995 Tee drain (water trap).

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(a) This part sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, an anesthesiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[52 FR 17734, May 11, 1987]

§ 868.3 Effective dates of_requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of

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