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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter HPart 864 → Subpart G


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES


Subpart G—Manual Hematology Devices


Contents
§864.6100   Bleeding time device.
§864.6150   Capillary blood collection tube.
§864.6160   Manual blood cell counting device.
§864.6400   Hematocrit measuring device.
§864.6550   Occult blood test.
§864.6600   Osmotic fragility test.
§864.6650   Platelet adhesion test.
§864.6675   Platelet aggregometer.
§864.6700   Erythrocyte sedimentation rate test.

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§864.6100   Bleeding time device.

(a) Identification. A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

(b) Classification. Class II (special 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 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]

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§864.6150   Capillary blood collection tube.

(a)  Identification. A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

(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 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 65 FR 2310, Jan. 14, 2000]

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§864.6160   Manual blood cell counting device.

(a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

(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 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

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§864.6400   Hematocrit measuring device.

(a) Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

(b) Classification. Class II (special 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 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]

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§864.6550   Occult blood test.

(a) Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

(b) Classification. Class II (special controls). A control intended for use with an occult blood test 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 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

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§864.6600   Osmotic fragility test.

(a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.

(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 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

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§864.6650   Platelet adhesion test.

(a) Identification. A platelet adhesion test is a device used to determine in vitro platelet function.

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

[45 FR 60608, Sept. 12, 1980]

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§864.6675   Platelet aggregometer.

(a) Identification. A platelet aggregometer 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 60608, Sept. 12, 1980]

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§864.6700   Erythrocyte sedimentation rate test.

(a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

(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 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

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