Lapas attēli
PDF
ePub

ment of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's

tissues are injured by autoantibodies).

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

own

(b) Classification. Class II (performance standards). $ 866.5620 Alpha-2-macroglobulin

immunological test system. (a) Identification. An alpha-2macroglobulin 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).

(a)

8866.5680 Myoglobin immunological test system.

Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

(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).

8866.5640 Infectious mononucleosis

immunological test system. (a) Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

(b) Classification. Class II (performance standards). [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]

$ 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]

$ 866.5660 Multiple autoantibodies

immunological test system. (a) Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to

by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measure

$ 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 8 866.9. (47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

measure

(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]

8 866.5735 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)

8866.5775 Rheumatoid factor immuno

logical 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).

$ 866.5750 Radioallergosorbent (RAST)

immunological test system. (a) Identification.

A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

(b) Classification. Class II (performance standards). $ 866.5765 Retinol-binding protein

immunological test system. (a) Identification. A retinol-binding protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of this protein may aid in the diagnosis of kidney disease and in monitoring patients with kidney transplants.

$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 disease.

(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 nontoxic goiter (enlargement of thyis exempt from the premarket notifica- roid gland), Grave's disease (enlargetion procedures in subpart E of part 807 ment of the thyroid gland with protruof this chapter.

sion of the eyeballs), and cancer of the

thyroid. (54 FR 25047, June 12, 1989)

(b) Classification. Class II (perform8866.5820 Systemic

lupus ance standards). erythematosus immunological test system.

8866.5880 Transferrin immunological

test system. (a) Identification. A systemic lupus

(a) erythematosus (SLE) immunological

Identification. A transferrin test system is a device that consists of

immunological test system is a device the reagents used to measure by

that consists of the reagents used to immunochemical techniques the

measure by immunochemical techautoimmune antibodies in serum and

niques the transferrin (an iron-binding other body fluids that react with cel

and transporting serum protein) in lular nuclear double-stranded

serum, plasma, and other body fluids. deoxyribonucleic acid (DNA) or other

Measurement of transferrin levels aids nuclear constituents that are specifi

in the diagnosis of malnutrition, acute cally diagnostic of SLE. Measurement

inflammation, infection, and red blood of nuclear double-stranded DNA anti

cell disorders, such as iron deficiency bodies aids in the diagnosis of SLE (a

anemia. multisystem autoimmune disease in

(b) Classification. Class II (performwhich tissues are attacked by the per

ance standards). son's own antibodies). (b) Classification. Class II (perform

$866.5890 Inter-alpha trypsin inhibitor

immunological test system. ance standards).

(a) Identification. An inter-alpha $ 866.5860 Total spinal fluid immuno- trypsin inhibitor immunological test logical test system.

system is a device that consists of the reagents

used (a) Identification. A total spinal fluid

to measure by immunological test system is a device

immunochemical techniques the interthat consists of the reagents used to

alpha trypsin inhibitor (a protein) in measure by immunochemical tech

serum and other body fluids. Measureniques the total protein in cerebro

ment of inter-alpha trypsin inhibitor spinal fluid. Measurement of spinal

may aid in the diagnosis of acute bacfluid proteins may aid in the diagnosis

terial infection and inflammation. of multiple sclerosis and other diseases

(b) Classification. Class I (general conof the nervous system.

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

premarket notification procedures in is exempt from the premarket notifica

subpart E of part 807 of this chapter tion procedures in subpart E of part 807

subject to $866.9. of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 53

FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, (47 FR 50823, Nov. 9, 1982, as amended at 61

2000) FR 1119, Jan. 16, 1996) 8 866.5870 Thyroid autoantibody Subpart G-Tumor Associated immunological test system.

Antigen immunological Test (a) Identification. A thyroid Systems autoantibody immunological test system is a device that consists of the re

$ 866.6010 Tumor-associated antigen agents used to measure by

immunological test system. immunochemical techniques the thy- (a) Identification. A tumor-associated roid autoantibodies (antibodies pro- antigen immunological test system is a duced against the body's own tissues). device that consists of reagents used to Measurement of thyroid autoantibodies qualitatively or quantitatively measmay aid in the diagnosis of certain thy- ure, by immunochemical techniques, roid disorders, such as Hashimoto's dis- tumor-associated antigens in serum, ease (chronic lymphocytic thyroiditis), 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)

868.1880 Pulmonary-function data calcu

lator. 868.1890 Predictive pulmonary-function

value calculator. 868.1900 Diagnostic pulmonary-function in

terpretation calculator. 868.1910 Esophageal stethoscope. 868.1920 Esophageal stethoscope with elec

trical conductors. 868.1930 Stethoscope head. 868.1965 Switching valve (ploss). 868.1975 Water vapor analyzer.

PART 868-ANESTHESIOLOGY

DEVICES

Subpart A-General Provisions

Sec. 868.1 Scope. 868.3 Effective dates of requirement for pre

market approval. 868.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart C-Monitoring Devices 868.2025 Ultrasonic air embolism monitor. 868.2300 Bourdon gauge flowmeter. 868.2320 Uncompensated thorpe tube flow

meter. 868.2340 Compensated thorpe tube flow

meter. 868.2350 Gas calibration flowmeter. 868.2375 Breathing frequency monitor. 868.2380 Nitric oxide analyzer. 868.2385 Nitrogen dioxide analyzer. 868.2450 Lung water monitor. 868.2480 Cutaneous carbon dioxide (PCO2)

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 stimu

lator. 868.2875 Differential pressure transducer. 868.2885 Gas flow transducer. 868.2900 Gas pressure transducer.

Subpart B-Diagnostic Devices 868.1030 Manual algesimeter. 868.1040 Powered algesimeter. 868.1075 Argon gas analyzer. 868.1100 Arterial blood sampling kit. 868.1120 Indwelling blood oxyhemoglobin

concentration analyzer. 868.1150 Indwelling blood carbon dioxide

partial pressure (Pco2) analyzer. 868.1170 Indwelling blood hydrogen ion con

centration (pH) analyzer. 868.1200 Indwelling blood oxygen partial

pressure (Po2) analyzer. 868.1400 Carbon dioxide gas analyzer. 868.1430 Carbon monoxide gas analyzer. 868.1500 Enflurane gas analyzer. 868.1575 Gas collection vessel. 868.1620 Halothane gas analyzer. 868.1640 Helium gas analyzer. 868.1670 Neon gas analyzer. 868.1690 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.

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 airSubpart G-Miscellaneous

way obstruction. 868.5120 Anesthesia conduction catheter. 868.5130 Anesthesia conduction filter. 868.5140 Anesthesia conduction kit. 868.5150 Anesthesia conduction needle. 868.5160 Gas machine for anesthesia or anal

gesia. 868.5165 Nitric oxide administration appa

ratus. 868.5170 Laryngotracheal topical anesthesia

applicator. 868.5180 Rocking bed. 868.5220 Blow bottle. 868.5240 Anesthesia breathing circuit. 868.5250 Breathing circuit circulator. 868.5260 Breathing circuit bacterial filter. 868.5270 Breathing system heater. 868.5280 Breathing tube support. 868.5300 Carbon dioxide absorbent.

868.6100 Anesthetic cabinet, table, or tray. 868.6175 Cardiopulmonary emergency cart. 868.6225 Nose clip. 868.6250 Portable air compressor. 868.6400 Calibration gas. 868.6700 Anesthesia stool. 868.6810 Tracheobronchial suction catheter. 868.6820 Patient position support. 868.6885 Medical gas yoke assembly.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

SOURCE: 47 FR 31142, July 16, 1982, unless otherwise noted.

Subpart A-General Provisions

868.5310 Carbon dioxide absorber. 868.5320 Reservoir bag. 868.5330 Breathing gas mixer. 868.5340 Nasal oxygen cannula. 868.5350 Nasal oxygen catheter. 868.5365 Posture chair for cardiac or pul

monary treatment. 868.5375 Heat and moisture condenser (arti

ficial nose). 868.5400 Electroanesthesia apparatus. 868.5420 Ether hook. 868.5430 Gas-scavenging apparatus. 868.5440 Portable oxygen generator. 868.5450 Respiratory gas humidifier. 868.5460 Therapeutic humidifier for home

use. 868.5470 Hyperbaric chamber. 868.5530 Flexible laryngoscope. 868.5540 Rigid laryngoscope. 868.5550 Anesthetic gas mask. 868.5560 Gas mask head strap. 868.5570 Nonrebreathing mask. 868.5580 Oxygen mask. 868.5590 Scavenging mask. 868.5600 Venturi mask. 868.5610 Membrane lung for long-term pul

monary support. 868.5620 Breathing mouthpiece. 868.5630 Nebulizer. 868.5640 Medicinal nonventilatory nebulizer

(atomizer). 868.5650 Esophageal obturator. 868.5655 Portable liquid oxygen unit. 868.5665 Powered percussor. 868.5675 Rebreathing device. 868.5690 Incentive spirometer. 868.5700 Nonpowered oxygen tent. 868.5710 Electrically powered oxygen tent. 868.5720 Bronchial tube. 868.5730 Tracheal tube. 868.5740 Tracheal/bronchial differential ven

tilation tube. 868.5750 Inflatable tracheal tube cuff. 868.5760 Cuff spreader. 868.5770 Tracheal tube fixation device. 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 venti

lator. 868.5955 Intermittent mandatory ventila

tion attachment. 868.5965 Positive end expiratory pressure

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

8868.1 Scope.

(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 а 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)

8 868.3 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

« iepriekšējāTurpināt »