§ 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 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 of 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] Subpart C-Clinical Laboratory § 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 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. § 862.2100 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. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988] §862.2140 Centrifugal chemistry analyzer 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.2150 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 subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.2160 Discrete photometric chemistry analyzer for clinical use. (a) Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units. (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] § 862.2170 Micro chemistry analyzer for clinical use. (a) Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2230 Chromatographic separation material for clinical use. (a) Identification. A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution. (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 61 FR 1119, Jan. 16, 1996] § 862.2250 Gas liquid chromatography system for clinical use. (a) Identification. A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating. (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] § 862.2260 High pressure liquid chromatography system for clínical use. (a) Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity. (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] § 862.2270 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] § 862.2300 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 a 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] § 862.2310 Clinical sample concen trator. (a) Identification. A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, 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] § 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] §862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. (a) Identification. A densitometer/ scanner (integrating, reflectance, thinlayer or 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 on a 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] 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] § 862.2500 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] § 862.2540 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] §862.2560 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] (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] § 862.2700 Nephelometer for clinical use. (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] § 862.2720 Plasma oncometer for clinical use. (a) Identification. A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to 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] § 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 are 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] § 862.2750 Pipetting and diluting system 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. (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] § 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] § 862.2850 Atomic absorption spectrophotometer 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] § 862.2860 Mass spectrometer for clinical use. (a) Identification. A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and |