INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

{0}------------------------------------------------ 4/21/99 K99 0915 # 510k Summary of Safety and Effectiveness . his summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: ### Applicant Information: | Date Prepared: | March 12, 1999 | |----------------|------------------------------------------| | Name: | Stellar Bio Systems, Inc. | | Address: | 9075 Guilford Road<br>Columbia, MD 21046 | | Contact Person: | John Brewer | |-----------------|--------------| | PhoneNumber. | 410-381-8550 | | Fax Number. | 410-381-8984 | #### Device Information: | Trade Name: | Indirect Fluorescence Assay for Anti-Nuclear Antibodies (ANA) IgG Antibody | |----------------------|----------------------------------------------------------------------------| | Common Name: | ANA IgG IFA Test | | Classification Name: | ANA IgG Serological Reagent | quivalent Device: . H A Device Description: The ANA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to ANA antigens in human serum. Intended Use: The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases. #### Principle of Procedure: Stellar Bio Systems' fluorescent antibody assays use the indirect method of antibody detection and titer determination. Diluted patient serum samples are applied to fixed antigens provided on paint delineated wells on glass microscope slides. During a 30 minute incubation, antibody specific for ANA antigens forms an antigen/antibody complex with the fixed antigens. In a brief washing step, nonspecific antibody and other unreacted serum proteins are eliminated. Fluorescein-conjugated goat anti-human IgG is then applied to the wells of the glass slide. The anti-IgG conjugate combines with human IgG, if present, during a 30 minute incubation. After a brief wash to remove unreacted conjugate, the slides are viewed by fluorescence microscopy. A positive antibody reaction is denoted by bright green fluorescence at the antigen sites. {1}------------------------------------------------ #### Performance Characteristics 1. Relative Sensitivity and Specificity - The Stellar ANA IFA kit was evaluated relative to a commercially available ANA IFA. The samples were frozen retrospective sera. 100 sera were from patients diagnosed with SLE. Ninety-nine sera were from normals with various ages, gender, and geographical areas. The data in Table 1 summarizes the data. ## Table 1 Relative Sensitivity and Specificity of the Stellar ANA IFA Kit Relative to Alternate IFA | | | Positive | Negative | Total | |------------------|----------|----------|----------|-------| | Alternate<br>IFA | Positive | 100 | 7 | 107 | | | Negative | 2 | 88 | 90 | | | Total | 102 | 95 | 197 | | | 95% Confidence Interval | |----------------------------------------|-------------------------| | Relative Sensitivity = 100/107 = 93.5% | 87.0% - 97.3% | | Relative Specificity = 88/90 = 97.8% | 92.2% - 99.7% | | Relative Agreement = 188/197 = 95.4% | 91.5% - 97.9% | Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease. - 2. Titer Agreement: 25 positive sera were serially two-fold diluted and the endpoint titer was determined on the Stellar ANA IFA and a commercially available ANA IFA. The endpoint titer results are as follows. - Stellar ANA IFA {2}------------------------------------------------ | Identical Titer | 12/25 | |---------------------------|-------| | ± one, two-fold dilution | 11/25 | | ± two, two-fold dilutions | 2/25 | . 3. Reproducibility: Three positive with various titers (1:80, 1:640, 1:2560) and one negative sera were serially diluted and assayed three times each on three different assays. 35/36 of the end point titers were identical. 1/36 of the end point titers was within ± one, two-fold dilution. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 1 1999 Mr. John Brewer Stellar Bio Systems, Inc. 9075 Guilford Road Columbia, Maryland 21046 Re: K990915 > Trade Name: Indirect Fluorescence Assay for Anti-Nuclear Antibodies (ANA) IgG Antibody Regulatory Class: II Product Code: DHN Dated: March 12, 1999 Received: March 18, 1999 Dear Mr. Brewer: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Dutman Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 K 990915 510(k) Number: Not Known Device Name: Indirect Fluorescence Assay for Anti-Nuclear Antibodies (ANA) IgG Antibody Indications For Use: The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases. Cste E. Mafin (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K990915 PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (Per 21 CFR 801.109) OR Over-The Counter Use (Optional Format 1-2-96)