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(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 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000)

$864.2360 Mycoplasma detection

media and components. (a) Identification. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.

(b) Classification. Class I. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

Subpart D-Pathology Instrumentation and Accessories $ 864.3010 Tissue processing equip

ment. (a) Identification. Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is 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 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

$ 864.2800 Animal and human sera.

(a) Identification. Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.

(b) Classification. Class I. The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

8 864.2875 Balanced salt solutions or

formulations. (a) Identification. A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.

(b) Classification. Class I. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

8 864.3250 Specimen transport and

storage container. (a) Identification. A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container.

(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of 8820.180 of this chapter, with respect to general requirements concerning records, and $ 820.198 of this chapter, with respect to complaint files.

(54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000)

194-069 D-01--8

EFFECTIVE DATE NOTE: At 65 FR 18234, Apr. 2001, the effective date was delayed until 7, 2000, 8 864.3250 was amended by adding a June 8, 2001. sentence to the end of paragraph (a), effective Apr. 9, 2001. At 66 FR 17359, Mar. 30, 2001, 8 864.3300 Cytocentrifuge. the effective date was delayed until June 8,

(a) Identification. A cytocentrifuge is 2001. For the convenience of the user, the added text is set forth as follows:

a centrifuge used to concentrate cells

from biological cell suspensions (e.g., 8864.3250 Specimen transport and storage cerebrospinal fluid) and to deposit containers.

these cells on a glass microscope slide (a) *** This section does not apply to for cytological examination. specimen transport and storage containers (b) Classification. Class I. The device that are intended for use as part of an over- is exempt from the premarket notificathe-counter test sample collection system tion procedures in subpart E of part 807 for drugs of abuse testing.

of this chapter.
(45 FR 60588, Sept. 12, 1980, as amended at 54

FR 25044, June 12, 1989) 8864.3260 OTC test sample collection 8 864.3400 Device for sealing microsecsystems for drugs of abuse testing.

tions. (a) Identification. An over-the-counter (a) Identification. device for sealing (OTC) test sample collection system microsections is an automated instrufor drugs of abuse testing is a device ment used to seal stained cells and intended to: Collect biological speci- microsections for histological and mens (such as hair, urine, sweat, or sa- cytological examination. liva), outside of a medical setting and (b) Classification. Class I. The device not on order of a health care profes- is exempt from the premarket notificasional (e.g., in the home, insurance, tion procedures in subpart E of part 807 sports, or workplace setting); maintain

of this chapter. the integrity of such specimens during (45 FR 60589, Sept. 12, 1980, as amended at 54 storage and transport in order that the FR 25044, June 12, 1989) matter contained therein can be tested in a laboratory for the presence of

8 864.3600 Microscopes and acces

sories. drugs of abuse or their metabolites; and provide access to test results and (a) Identification. Microscopes and accounseling. This section does not apply cessories are optical instruments used to collection, transport, or laboratory to enlarge images of specimens, preptesting of biological specimens for the arations, and cultures for medical purpresence of drugs of abuse or their me- poses. Variations of microscopes and tabolites that is performed to develop accessories (through a change in the evidence for law enforcement purposes. light source) used for medical purposes (b) Classification. Class I (general con

include the following: trols). The device is exempt from the

(1) Phase contrast microscopes, premarket notification requirements

which permit visualization of in part 807, subpart E of this chapter unstained preparations by altering the subject to the limitations in $ 864.9 if it

phase relationship of light that passes is sold, distributed, and used in accord

around the object and through the obance with the restrictions set forth in ject. 8809.40 of this chapter. If the device is

(2) Fluorescense microscopes, which not labeled or otherwise represented as

permit examination of specimens sterile, it is exempt from the current

stained with fluorochromes that fluogood manufacturing practice regula

resce under ultraviolet light. tions in part 820 of this chapter, with

(3) Inverted stage microscopes, which the exception of $820.198 of this chapter permit examination of tissue cultures with respect to complaint files.

other biological specimens con

tained in bottles or tubes with the [65 FR 18234, Apr. 7, 2000]

light source mounted above the speciEFFECTIVE DATE NOTE: At 65 FR 18234, Apr.

men. 7, 2000, $864.3260 was added to subpart D, ef- (b) Classification. Class I. These defective Apr. 9, 2001. At 66 FR 17359, Mar. 30, vices are exempt from the premarket

or

notification procedures in subpart E of part 807 of this chapter. The devices are also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of 8820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

(45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989)

$864.3800 Automated slide stainer.

(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989) 8864.3875 Automated tissue processor.

(a) Identification. An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989)

priate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is 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 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 62 FR 62260, Nov. 21, 1997]

Subpart E-Specimen Preparation

Reagents $864.4010 General purpose reagent.

(a) A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appro

8 864.4020 Analyte specific reagents.

(a) Identification. Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

(1) In vitro diagnostic manufacturers; or

(2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

(b) Classification. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, the device described in paragraph (b)(3) of this section. See $ 864.3.

(2) For postamendments ASR's; November 23, 1998.

(d) Restrictions. Restrictions on the sale, distribution and use of ASR's are set forth in 8 809.30 of this chapter.

(62 FR 62260, Nov. 21, 1997)

these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter.

(2) Class II (special controls/guidance documents), when the analyte is used in blood banking tests that have been classified as class II devices (e.g., certain cytomegalovirus serological and treponema pallidum nontreponemal test reagents). Guidance Documents:

1. “Specifications for Immunological Testing for Infectious Disease; Approved Guideline," NCCLS Document ILA18-A, December 1994.

2. “Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Tentative Guideline," NCCLS Document KGP10-T, December 1993.

3. “Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium spp," FDA, July 6, 1993, and its “Attachment 1,” February 28, 1994.

4. "Draft Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms,” FDA, July 6, 1993.

5. The Center for Biologics Evaluation and Research, FDA, “Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type I” (54 FR 48943, November 28, 1989).

(3) Class III (premarket approval), when:

(i) The analyte is intended as a component in a test intended for use in the diagnosis of a contagious condition that is highly likely to result in a fatal outcome and prompt, accurate diagnosis offers the opportunity to mitigate the public health impact of the condition

(e.g.,

human immunodeficiency virus (HIV/AIDS)or tuberculosis (TB)); or

(ii) The analyte is intended as a component in a test intended for use in donor screening for conditions for which FDA has recommended or required testing in order to safeguard the blood supply or establish the safe use of blood and blood products (e.g., tests for hepatitis or tests for identifying blood groups).

(c) Date of 510(k), or date of PMA or notice of completion of a product development protocol is required. (1) Preamendments ASR's; No effective date has been established for the requirement for premarket approval for

8 864.4400 Enzyme preparations.

(a) Identification. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin);

(2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction);

(3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).

(b) Classification. Class I. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989)

Subpart F-Automated and SemiAutomated Hematology Devices

$ 864.5200 Automated cell counter.

(a) Identification. An automated cell counter is a fully-automated or semiautomated 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 nean 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)

globin (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]

$864.5220 Automated differential cell

counter. (a) Identification. An automated differential cell counter is a device used to identify and classify one or more of the formed elements of the blood.

(b) Classification. (1) Class II (performance standards) when the device is intended to flag or identify specimens containing abnormal blood cells.

(2) Class III (premarket approval) when the device is intended for other uses, including to count or classify abnormal cells of the blood.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device identified in paragraph (b)(2) of this section. See $ 864.3. (45 FR 60596, Sept. 12, 1980, as amended at 55 FR 23511, June 8, 1990)

$ 864.5350 Microsedimentation cen

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

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994)

8864.5240 Automated blood cell dilut.

ing 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)

$ 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]

$ 864.5260 Automated cell-locating de

vice. (a) Identification. An automated celllocating 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)

8 864.5425 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)

$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 hemo

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