[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.1860]

[Page 232-233]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864_HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
                       Subpart B_Biological Stains
 
Sec. 864.1860  Immunohistochemistry reagents 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, 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

[[Page 233]]

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 Sec. 864.3.

[63 FR 30142, June 3, 1998]