monitoring levels of theophylline to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3900 Tobramycin test system.

(a) Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. 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.

§ 862.3910 Tricyclic antidepressant drugs test system.

(a) Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in 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.

Sec.

Subpart J-Products Used In Establishments That Manufacture Blood and Blood Products 864.9050 Blood bank supplies. 864.9100 Empty container for the collection and processing of blood and blood components.

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 reagents 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 diagnostic use.

864.9650 Quality control kit for blood banking reagents.

864.9700 Blood storage refrigerator and blood storage freezer. 864.9750 Heat-sealing device. 864.9875 Transfer set.

AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).

Subpart A-General Provisions

§ 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 manufacturer who submits a premarket notification submission for a device under Part 807 may not show merely that the device is accurately described by the section title and iden

tification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.

[52 FR 17732, May 11, 1987]

§ 864.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

[52 FR 17732, May 11, 1987]

§ 864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonof ably foreseeable characteristics commercially distributed devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; e.g., the device is intended for a different medi

cal purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or

(b) The modified device operates using a different fundamental scientif. | ic technology than that in use in the device before May 28, 1976, 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 a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology. [54 FR 25043, June 12, 1989]

(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 manu- | facturing 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]

Subpart C-Cell And Tissue Culture Products

§ 864.2220 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 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]

§ 864.2240 Cell and tissue culture supplies 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 or 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]

§ 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]