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good manufacturing practice regulations in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

8862.2100 Calculator/data processing

module for clinical use. (a) Identification. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.

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

$ 862.1820 Xylose test system.

(a) Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

(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 8 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000) 8 862.1825 Vitamin D test system.

(a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination

25hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

(b) Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:

(1) Labeling in conformance with 21 CFR 809.10 and

(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards. (63 FR 40366, July 29, 1998)

(52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]

of

8862.2140 Centrifugal chemistry ana

lyzer for clinical use. (a) Identification. A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

(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 8 862.9.

(52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

Subpart C-Clinical Laboratory

Instruments

8 862.2050 General purpose laboratory

equipment labeled or promoted for

a specific medical use. (a) Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

(b) Classification. Class I. The device identified in paragraph (a) of this section is exempt from the premarket notification procedures in subpart E of part 807 and is exempt from the current

8862.2150 Continuous flow sequential

multiple chemistry analyzer for

clinical use. (a) Identification. A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

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

in subpart E of part 807 of this chapter 8862.2230 Chromatographic separasubject to $ 862.9.

tion material for clinical use. (52 FR 16122, May 1, 1987, as amended at 65

(a) Identification. A chromatographic FR 2308, Jan. 14, 2000)

separation material for clinical use is a

device accessory (e.g., ion exchange $ 862.2160 Discrete photometric chem- absorbents, ion exchagne resins, and istry analyzer for clinical use.

ion papers) intended for use in ion ex(a) Identification. A discrete photo- change chromatography, a procedure in

which a compound is separated from a metric chemistry analyzer for clinical use is a device intended to duplicate

solution. manual analytical procedures by per

(b) Classification. Class I. The device

is exempt from the premarket notificaforming automatically various steps

tion procedures in subpart E of part 807 such as pipetting, preparing filtrates,

of this chapter. heating, and measuring color intensity. This device is intended for use in con

(52 FR 16122, May 1, 1987, as amended at 61

FR 1119, Jan. 16, 1996) junction with certain materials to measure a variety of analytes. Dif

8 862.2250 Gas liquid chromatography ferent models of the device incorporate system for clinical use. various instrumentation such as micro

(a) Identification. A gas liquid chroanalysis apparatus, double beam, sin

matography system for clinical use is a gle, or dual channel photometers, and

device intended to separate one or bichromatic

2-wavelength

more drugs or compounds from a mixphotometers. Some models of the de

ture. Each of the constituents in a vavice may include reagent-containing porized mixture of compounds is sepacomponents that may also serve as re- rated according to its vapor pressure. action units.

The device may include accessories (b) Classification. Class I (general con- such as columns, gases, column suptrols). The device is exempt from the ports, and liquid coating. premarket notification procedures in (b) Classification. Class I (general consubpart E of part 807 of this chapter trols). The device is exempt from the subject to $862.9.

premarket notification procedures in

subpart E of part 807 of this chapter (52 FR 16122, May 1, 1987, as amended at 65

subject to 8 862.9. FR 2309, Jan. 14, 2000)

(52 FR 16122, May 1, 1987, as amended at 65 8862.2170 Micro chemistry analyzer FR 2309, Jan. 14, 2000) for clinical use.

8862.2260 High pressure liquid chro(a) Identification. A micro chemistry

matography system for clinical use. analyzer for clinical use is a device intended to duplicate manual analytical

(a) Identification. A high pressure liqprocedures by performing automati

uid chromatography system for clinical cally various steps such as pipetting,

use is a device intended to separate one preparing filtrates, heating, and meas

or more drugs or compounds from a so

lution by processing the mixture of uring color intensity. The distinguishing characteristic of the device is

compounds (solutes) through a column

packed with materials of uniform size that it requires only micro volume

(stationary phase) under the influence samples obtainable from pediatric pa

of a high pressure liquid (mobile tients. This device is intended for use

phase). Separation of the solutes ocin conjunction with certain materials

curs either by absorption, sieving, parto measure a variety of analytes.

tition, or selective affinity. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the

trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to $862.9.

subject to $862.9. (52 FR 16122, May 1, 1987, as amended at 65 (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

FR 2309, Jan. 14, 2000)

and other body fluids before the fluids are analyzed.

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

(52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995]

8862.2270 Thin-layer chromatography

system for clinical use. (a) Identification. A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

(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 $862.9. Particular components of TLC systems, i.e., the thinlayer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180 of this chapter, with respect to general requirements concerning records, and $ 820.198 of this chapter, with respect to complaint files. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

$ 862.2320 Beta or gamma counter for

clinical use. (a) Identification. A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995)

or

or

8 862.2300 Colorimeter, photometer, or

spectrophotometer for clinical use. (a) Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include monochromator to produce light of a specific wavelength.

(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 8 862.9.

$ 862.2400 Densitometer/scanner (inte

grating, reflectance, TLC,
radiochromatogram)

for clinical use. (a) Identification. A densitometer/ scanner (integrating, reflectance, thinlayer chromatography, radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element radiochromatogram.

(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 8 862.9.

a

on

a

(52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

(52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

concen

8 862.2310 Clinical sample

trator. (a) Identification. A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid,

$ 862.2485 Electrophoresis apparatus

for clinical use. (a) Identification. An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995)

8862.2560 Fluorometer for clinical use.

(a) Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.

(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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

8862.2500 Enzyme analyzer for clinical

use.

(a) Identification. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related 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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

8 862.2680 Microtitrator for clinical

use. (a) Identification. A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro" volume of a known standardized solution.

(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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

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8862.2540 Flame emission photometer

for clinical use. (a) Identification. A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those 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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

(a) Identification. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.

(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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

8 862.2720 Plasma oncometer for clin.

ical use. (a) Identification. A plasma oncometer for clinical use is a device intended to (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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

to

measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large

pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995)

8 862.2800 Refractometer for clinical

use. (a) Identification. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995)

are

8 862.2730 Osmometer for clinical use.

(a) Identification. An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions

separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical

properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid 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 $862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

8 862.2850 Atomic absorption spectro

photometer for clinical use. (a) Identification. An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and metals (e.g., lead and mercury) in human specimens. The metal elements are identified according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

(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 $ 862.9. (52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000)

8 862.2750 Pipetting and diluting sys

tem for clinical use. (a) Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

$ 862.2860 Mass spectrometer for clin.

ical use. (a) Identification. A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and

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