(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.
(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.
(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 § 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 § 809.30 of this chapter.