[Title 21 CFR F] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION,] [Subchapter F - BIOLOGICS] [Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS] [Subpart F - Anti-Human Globulin] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 7 1996-04-01 1996-04-01 false Anti-Human Globulin F Subpart F FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Subpart F--Anti-Human Globulin Sec. 660.50 Anti-Human Globulin. (a) Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in Sec. 660.55(d) and be [[Page 161]] prepared by a method demonstrated to yield consistently a sterile product. (b) Source. The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts. [50 FR 5579, Feb. 11, 1985] Sec. 660.51 Processing. (a) Processing method. (1) The processing method shall be one that has been shown to yield consistently a specific, potent final product, free of properties that would adversely affect the product for its intended use throughout its dating period. (2) Anti-IgG, -C3d (polyspecific) reagents and anti-IgG products may be colored green. (3) Only that material which has been fully processed, thoroughly mixed in a single vessel, and sterile filtered shall constitute a lot. Each lot shall be identified by a lot number. (4) A lot may be subdivided into clean, sterile vessels. Each subdivision shall constitute a sublot which shall be identified by the lot number to which has been added a distinctive prefix or suffix. If lots are to be subdivided, the manufacturer shall include this information in the license application and on the protocol. The manufacturer shall describe the test specifications to verify that each sublot is identical to other sublots of the lot. (b) Final containers and dropper assemblies. (1) Final containers and dropper assemblies shall be clean. (2) Final containers and dropper pipettes shall be colorless and sufficiently transparent to permit observation of the contents for presence of particulate matter or increased turbidity. (c) Date of manufacture. The date of manufacture shall be the date the manufacturer begins the last entire group of potency tests. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985] Sec. 660.52 Reference preparations. Reference Anti-Human Globulin preparations shall be obtained from the Center for Biologics Evaluation and Research (HFB-221), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, and shall be used as described in the accompanying package insert for determining the potency of Anti-Human Globulin. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11015, Mar. 26, 1990] Sec. 660.53 Controls for serological procedures. Red blood cells sensitized with complement shall be tested with appropriate positive and negative control antisera. All tests shall be performed in accordance with serological testing procedures approved by the Director, Center for Biologics Evaluation and Research (HFB-1), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990] Sec. 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research (HFB-1), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892: (a) Potency tests for determining anti-IgG and anti-complement activity. (b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990] [[Page 162]] Sec. 660.55 Labeling. In addition to the applicable labeling requirements of Secs. 610.62 through 610.65 and Sec. 809.10 of this chapter, and in lieu of the requirements in Secs. 610.60 and 610.61 of this chapter, the following requirements shall be met: (a) Final container label--(1) Color coding. The main panel of the final container label of all Anti-IgG, -C3d (polyspecific) reagents shall be white or colorless and printing shall be solid dark contrasting lettering. The main panel of the final container label of all other Anti-Human Globulin reagents shall be black with solid white lettering. A logo or company name may be placed on the final container label, however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel. (2) Required information. The proper name ``Anti-Human Globulin'' need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information: (i) Name of the antibody or antibodies present as set forth in paragraph (d) of this section. Anti-Human Globulin may contain one or more antibodies to either immunoglobulins or complement components but the name of each significant antibody must appear on the final container label (e.g., anti-C3b, -C3d, -C4d). The final container labels of polyspecific Anti-Human Globulin are not required to identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin shall be accurately described in the package insert. (ii) Name, address, and license number of the manufacturer. (iii) Lot number, including any sublot designations. (iv) Expiration date. (v) Source of the product. (vi) Recommended storage temperature in degrees Celsius. (vii) Volume of product. (viii) Appropriate cautionary statement if the Anti-Human Globulin is not polyspecific. For example, ``DOES NOT CONTAIN ANTIBODIES TO IMMUNOGLOBULINS'' or ``DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT COMPONENTS.'' (ix) If the final container is not enclosed in a package, all items required for a package label shall appear on the container label. (3) Lettering size. The type size for the designation of the specific antibody on the label of a final container shall be not less than 12 point, unless otherwise approved by the Director, Center for Biologics Evaluation and Research (HFB-1). The prefix anti- and other parts of the name such as polyspecific may appear in smaller type. (4) Visual inspection. When the label has been affixed to the final container, a sufficient area of the container shall remain uncovered for its full length or for no less than 5 millimeters of the lower circumference to permit inspection of the contents. (b) Package label. The following items shall appear either on the package label or on the final container label if see-through packaging is used: (1) Proper name of the product, and the name of the antibody or antibodies as listed in paragraph (d) of this section. (2) Name, address (including zip code), and license number of the manufacturer. (3) Lot number, including any sublot designations. (4) Expiration date. (5) Preservative(s) used and its concentration. (6) Number of containers, if more than one. (7) Recommended storage temperature in degrees Celsius. (8) Source of the product. (9) Reference to enclosed package insert. (10) The statement: ``For In Vitro Diagnostic Use.'' (11) The statement: ``Meets FDA Potency Requirements.'' (12) A statement of an observable indication of an alteration of the product, e.g., turbidity, color change, precipitate, that may indicate possible deterioration of the product. (13) Appropriate cautions. (c) Package insert. Each final container of Anti-Human Globulin shall be [[Page 163]] accompanied by a package insert meeting the requirements of Sec. 809.10 of this chapter. If two or more final containers requiring identical package inserts are placed in a single package, only one package insert per package is required. (d) Names of antibodies. ------------------------------------------------------------------------ Antibody designation on container label Definition ------------------------------------------------------------------------ (1) Anti-IgG, -C3d; Polyspecific...... Contains anti-IgG and anti-C3d (may contain other anticomplement and anti- immunoglobulin antibodies). (2) Anti-IgG.......................... Contains anti-IgG with no anti- complement activity (not necessarily gamma chain specific). (3) Anti-IgG; heavy chains............ Contains only antibodies reactive against human gamma chains. (4) Anti-C3b.......................... Contains only C3b antibodies with no anti-immunoglobulin activity. Note: The antibody produced in response to immunization is usually directed against the antigenic determinant which is located in the C3c subunit; some persons have called this antibody ``anti-C3c.'' In product labeling, this antibody should be designated anti-C3b. (5) Anti-C3d.......................... Contains only C3d antibodies with no anti-immunoglobulin activity. (6) Anti-C4b.......................... Contains only C4b antibodies with no anti-immunoglobulin activity. (7) Anti-C4d.......................... Contains only C4d antibodies with no anti-immunoglobulin activity. ------------------------------------------------------------------------ Anti-Human Globulin preparations may contain one or more of the antibody specificities listed in this paragraph as described in paragraph (a)(2)(i) of this section. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985; 50 FR 9800, Mar. 12, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 55 FR 11014, Mar. 26, 1990]