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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR864]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 864HEMATOLOGY AND PATHOLOGY DEVICES
 

Subpart F--Automated and Semi-Automated Hematology Devices

Sec. 864.5200 Automated cell counter.

(a)Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

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

[45 FR 60593, Sept. 12, 1980]

Sec. 864.5220 Automated differential cell counter.

(a)Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

(b)Classification. Class II (special controls). The special control for this device is the FDA document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA."

[67 FR 1607, Jan. 14, 2002]

Sec. 864.5240 Automated blood cell diluting apparatus.

(a)Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

(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 864.9.

[45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

Sec. 864.5260 Automated cell-locating device.

(a)Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

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

[45 FR 60597, Sept. 12, 1980]

Sec. 864.5300 Red cell indices device.

(a)Identification. A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.

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

[45 FR 60597, Sept. 12, 1980]

Sec. 864.5350 Microsedimentation centrifuge.

(a)Identification. A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38789, July 25, 2001]

Sec. 864.5400 Coagulation instrument.

(a)Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

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

[45 FR 60598, Sept. 12, 1980]

Sec. 864.5425 Multipurpose system for in vitro coagulation studies.

(a)Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

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

[45 FR 60599, Sept. 12, 1980]

Sec. 864.5600 Automated hematocrit instrument.

(a)Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

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

[45 FR 60600, Sept. 12, 1980]

Sec. 864.5620 Automated hemoglobin system.

(a)Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

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

[45 FR 60601, Sept. 12, 1980]

Sec. 864.5680 Automated heparin analyzer.

(a)Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

(b)Classification. Class II (special controls).

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]

Sec. 864.5700 Automated platelet aggregation system.

(a)Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

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

[45 FR 60602, Sept. 12, 1980]

Sec. 864.5800 Automated sedimentation rate device.

(a)Identification. An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

Sec. 864.5850 Automated slide spinner.

(a)Identification. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

(b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

[45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

Sec. 864.5950 Blood volume measuring device.

(a)Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.

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

[45 FR 60603, Sept. 12, 1980]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

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