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864.9 Limitations of exemptions from sec

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

Subpart B-Blological Stains

864.1850 Dye and chemical solution stains. 864.1860 Immunohistochemistry reagents

and kits.

Subpart C-Cell and Tissue Culture

Products

serum.

theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

(b) Classification. Class II. 8862.3900 Tobramycin test system.

(a) Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

(b) Classification. Class II. 8862.3910 Tricyclic antidepressant

drugs test system. (a) Identification. А tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs serum. The tricyclic antidepressant drugs include imipramine, desipramine,

amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

(b) Classification. Class II.

864.2220 Synthetic cell and tissue culture

media and components. 864.2240 Cell and tissue culture supplies and

equipment. 864.2260 Chromosome culture kit. 864.2280 Cultured animal and human cells. 864.2360 Mycoplasma detection media and

components. 864.2800 Animal and human sera. 864.2875 Balanced salt solutions or formula

tions.

Subpart D-Pathology Instrumentation and

Accessories 864.3010 Tissue processing equipment. 864.3250 Specimen transport and storage

container. 864.3260 OTC test sample collection systems

for drugs of abuse testing. 864.3300 Cytocentrifuge. 864.3400 Device for sealing microsections. 864.3600 Microscopes and accessories. 864.3800 Automated slide stainer. 864.3875 Automated tissue processor.

in

Subpart E-Specimen Preparation

Reagents

864.4010 General purpose reagent. 864.4020 Analyte specific reagents. 864.4400 Enzyme preparations.

8862.3950 Vancomycin test system.

(a) Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

(b) Classification. Class II.

Subpart F-Automated and Semi

Automated Hematology Devices 864.5200 Automated cell counter. 864.5220 Automated differential cell

counter. 864.5240 Automated blood cell diluting appa

ratus. 864.5260 Automated cell-locating device. 864.5300 Red cell indices device. 864.5350 Microsedimentation centrifuge. 864.5400 Coagulation instrument. 864.5425 Multipurpose system for in vitro

coagulation studies. 864.5600 Automated hematocrit instrument. 864.5620 Automated hemoglobin system. 864.5680 Automated heparin analyzer. 864.5700 Automated platelet aggregation

system. 864.5800 Automated sedimentation rate de

vice. 864.5850 Automated slide spinner.

PART 864-HEMATOLOGY AND

PATHOLOGY DEVICES

Subpart A-General Provisions

Sec. 864.1 Scope. 864.3 Effective dates of requirement for pre

market approval.

864.5950 Blood volume measuring device.

864.8200 Blood cell diluent. 864.8500 Lymphocyte separation medium. 864.8540 Red cell lysing reagent. 864.8625 Hematology quality control mix

ture. 864.8950 Russell viper venom reagent.

Subpart G-Manual Hematology Devices 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.

Subpart —Products Used In Establishments

That Manufacture Blood and Blood
Products

Subpart H-Hematology Kits and

Packages

864.7040 Adenosine triphosphate release

assay. 864.7060 Antithrombin III assay. 864.7100 Red blood cell enzyme assay. 864.7140 Activated whole blood clotting time

tests. 864.7250 Erythropoietin assay. 864.7275 Euglobulin lysis time tests. 864.7290 Factor deficiency test. 864.7300 Fibrin monomer paracoagulation

test. 864.7320 Fibrinogen/fibrin degradation prod

ucts assay. 864.7340 Fibrinogen determination system. 864.7360 Erythrocytic glucose-6-phosphate

dehydrogenase assay. 864.7375 Glutathione reductase assay. 864.7400 Hemoglobin Az assay. 864.7415 Abnormal hemoglobin assay. 864.7425 Carboxyhemoglobin assay. 864.7440 Electrophoretic hemoglobin anal

ysis system. 864.7455 Fetal hemoglobin assay. 864.7470 Glycosylated hemoglobin assay. 864.7490 Sulfhemoglobin assay. 864.7500 Whole blood hemoglobin assays. 864.7525 Heparin assay. 864.7660 Leukocyte alkaline phosphatase

test. 864.7675 Leukocyte peroxidase test. 864.7695 Platelet factor 4 radioimmuno

assay. 864.7720 Prothrombin consumption test. 864.7735 Prothrombin-proconvertin test and

thrombotest. 864.7750 Prothrombin time test. 864.7825 Sickle cell test. 864.7875 Thrombin time test. 864.7900 Thromboplastin generation test. 864.7925 Partial thromboplastin time tests.

864.9050 Blood bank supplies. 864.9100 Empty container for the collection

and processing of blood and blood compo

nents. 864.9125 Vacuum-assisted blood collection

system. 864.9145 Processing system for frozen blood. 864.9160 Blood group substances of

nonhuman origin for in vitro diagnostic

use. 864.9175 Automated blood grouping and

antibody test system. 864.9185 Blood grouping view box. 864.9195 Blood mixing devices and blood

weighing devices. 864.9205 Blood and plasma warming device. 864.9225 Cell-freezing apparatus and re

agents for in vitro diagnostic use. 864.9245 Automated blood cell separator. 864.9275 Blood bank centrifuge for in vitro

diagnostic use. 864.9285 Automated cell-washing centrifuge

for immuno-hematology. 864.9300 Automated Coombs test systems. 864.9320 Copper sulfate solution for specific

gravity determinations. 864.9400 Stabilized enzyme solution. 864.9550 Lectins and protectins. 864.9575 Environmental chamber for storage

of platelet concentrate. 864.9600 Potentiating media for in vitro di

agnostic use. 864.9650 Quality control kit for blood bank

ing reagents. 864.9700 Blood storage refrigerator and

blood storage freezer. 864.9750 Heat-sealing device. 864.9875 Transfer set.

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

Subpart A-General Provisions

Subpart Hematology Reagents 864.8100 Bothrops atrox reagent. 864.8150 Calibrator for cell indices. 864.8165 Calibrator for hemoglobin or hem

atocrit measurement. 864.8175 Calibrator for platelet counting. 864.8185 Calibrator for red cell and white

cell counting.

$ 864.1 Scope.

(a) This part sets forth the classification of hematology and pathology 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

a

manufacturer who submits pre- tion under section 515(b) of the act remarket notification submission for a quiring premarket approval for a dedevice under part 807 may not show vice, section 501(f)(1)(A) of the act apmerely that the device is accurately plies to the device. described by the section title and iden- (b) Any new, not substantially equivtification provisions of a regulation in alent, device introduced into commerthis part, but shall state why the de- cial distribution on or after May 28, vice is substantially equivalent to 1976, including a device formerly marother devices, as required by $ 807.87. keted that has been substantially al

(c) References in this part to regu- tered, is classified by statute (section latory sections of the Code of Federal 513(f) of the act) into class III without Regulations are to chapter I of title 21, any grace period and FDA must have unless otherwise noted.

issued an order approving a PMA or de

claring completed a PDP for the device (52 FR 17732, May 11, 1987)

before the device is commercially dis8864.3 Effective dates of requirement

tributed unless it is reclassified. If for premarket approval.

FDA knows that a device being comA device included in this part that is

mercially distributed may be a "new"

device as defined in this section beclassified into class III (premarket ap

cause of any new intended use or other proval) shall not be commercially distributed after the date shown in the

reasons, FDA may codify the statutory

classification of the device into class regulation classifying the device unless the manufacturer has

III for such new use. Accordingly, the

an approval under section 515 of the act (unless an

regulation for such a class III device exemption has been granted under sec

states that as of the enactment date of tion 520(g)(2) of the act). An approval

the amendments, May 28, 1976, the deunder section 515 of the act consists of

vice must have an approval under secFDA's issuance of an order approving

tion 515 of the act before commercial

distribution. an application for premarket approval (PMA) for the device or declaring com- (52 FR 17732, May 11, 1987) pleted a product development protocol (PDP) for the device.

$ 864.9 Limitations of exemptions from (a) Before FDA requires that a device

section 510(k) of the Federal Food, commercially distributed before the

Drug, and Cosmetic Act (the act). enactment date of the amendments, or The exemption from the requirement a device that has been found substan- of premarket notification (section tially equivalent to such a device, has 510(k) of the act) for a generic type of an approval under section 515 of the act class I or II device is only to the extent FDA must promulgate a regulation that the device has existing or reasonunder section 515(b) of the act requir- ably foreseeable characteristics of ing such approval, except as provided commercially distributed devices within paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associafter its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)(2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still subtive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for inlation for a device classified into class troduction into interstate commerce III in this part, the device may be com- for commercial distribution the device mercially distributed without FDA's when: issuance of an order approving a PMA (a) The device is intended for a use or declaring completed a PDP for the different from the intended use of a ledevice. If FDA promulgates a regula- gally marketed device in that generic

re

type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in $ 812.3(k) of this chapter; and

(9) For near patient testing (point of care). [65 FR 2310, Jan. 14, 2000)

Subpart B-Biological Stains $864.1850 Dye and chemical solution

stains. (a) Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic

histopathology, cytopathology, or hematology.

(b) Classification. Class I. These devices are exempt from the premarket notification procedures in subpart E of part 807. The devices are also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989) $ 864.1860 Immunohistochemistry

agents and kits. (a) Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's. (b) Classification

of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, notification procedures in subpart E of part 807 of this chapter. [45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.

(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA," Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.

(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.

(c) Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See $ 864.3. [63 FR 30142, June 3, 1998]

8 864.2240 Cell and tissue culture sup

plies and equipment. (a) Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

(b) Classification. Class I. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the devices are not labeled otherwise represented as sterile, they are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

or

$ 864.2260 Chromosome culture kit.

(a) Identification. A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

Subpart C-Cell And Tissue

Culture Products

8864.2220 Synthetic cell and tissue

culture media and components. (a) Identification. Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts, etc.) that are essential for the survival and development of cell lines of humans and other animals.

(b) Classification. Class I. These devices are exempt from the premarket

$864.2280 Cultured animal and human

cells. (a) Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

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