[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.4020]

[Page 217-218]
 
                        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 E--Specimen Preparation Reagents
 
Sec. 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,

[[Page 218]]

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 I/LA18-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 the device described in paragraph (b)(3) of this section. 
See Sec. 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 Sec. 809.30 of this chapter.

[62 FR 62260, Nov. 21, 1997]