DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

{0}------------------------------------------------ ## OCT 2 6 2001 K0124449 ### 510(k) Summary of Safety and Effectiveness This 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: K012449 ### Applicant Information: | Date Prepared: | October 17, 2001 | |----------------|-----------------------------------------| | Name: | Diamedix Corporation | | Address: | 2140 N. Miami Avenue<br>Miami, FL 33127 | | Contact Person: | Dr. Lynne Stirling | |-----------------|--------------------| | Phone Number: | 305-324-2354 | | Fax Number: | 305-324-2388 | ### Device Information: | Trade Name: | Is anti-Cardiolipin IgG/IgM Test System | |----------------------|-------------------------------------------| | Common Name: | Anti-Cardiolipin ELISA test | | Classification Name: | Anticardiolipin immunological test system | ### Equivalent Device: Orgentec Anti-cardiolipin ELISA Assay Device Description: The Is anti-Cardiolipin IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum Intended Use: The assay is intended for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum. The results of the assay can be used as an aid in the assessment of the risk of thrombosis in patients with SLE or SLE-like dosorders. ### Principle of the Procedure: The Is-anti-Cardiolipin IgG/IgM Test System is an indirect solid-phase enzyme immunoassay. Highly purified cardiolipin is coated onto plastic microwells and saturated with highly purified human (32-Glycoprotein I. Standards, controls and diluted patient samples are added to the wells. Any patient IgG or IgM antibodies in the sample bind to the well. Anti-human IgG or IgM horseradish peroxidase conjugate is then added After incubation and washing, a substrate solution is then added to each well. In the presence of bound enzyme, the substrate is converted to a blue colored product. After acid additon to stop the reaction, a yellow end product is formed that is read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of cardiolipin IgG or IgM antibodies in the sample. {1}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS ## Performance Characteristics Non-clinical studies were performed using the manual method and 6-point calibration unless otherwise indicated. ### A. 3-point vs 6-point calibration To demonstrate the equivalence of both calibration methods the results of 172 samples tested using the Is-anti-Cardiolipin IgG and 193 samples tested using the Is-anti-cardiolipin IgM calculated using either the 3-point or 6-point calibration systems were subjected to linear regression analysis. Scattergrams and regression lines of the results obtained with 95% confidence intervals are shown in FIGURES 1 and 2. Also included are the regression statistics. Image /page/1/Figure/5 description: The image contains two scatter plots comparing 3-point and 6-point result correlations for anti-Cardiolipin IgG and IgM. Figure 1 shows the correlation for IgG, with the equation Y = 2.4036 + 0.9996X, a sample size of 172, and a correlation coefficient of 0.9861. Figure 2 displays the correlation for IgM, with the equation Y = 0.5333 + 0.9411X, a sample size of 162, and a correlation coefficient of 0.9925. ### B. Relative Sensitivity and Specificity One hundred and seventy-two frozen retrospective sera were tested for IgG antibodies and one hundred and ninety--four frozen retrospective sera were tested for IgM antibodies using the Is-anti-Cardiolipin IgG/IgM Test Kit and a commercially available ELISA kit for detecting IgC and/or IgM cardiolipin antibodies. Based on the results of this testing the relative sensitivity, specificity and overall agreement were calculated. The resultsobtained are shown in TABLES 1 and 2. For anti-cardiolipin IgG, further resolution of the discordant samples showed that the four samples that were negative in the Is-anti-Cardiolipin IgG and positive by the other EIA were also negative by a referee EIA method. For anti-cardiolipin IgM, further resolution of the discordant samples showed that of the 16 samples negative in the Is-anti-Cardiolipin IgM and positive in the other EIA, thirteen were negative and three were positive by a referee method. #### TABLE 1 #### TABLE 2 | | | Is-anti-Cardiolipin IgG | | | |----------------------|------------|-------------------------|-------------------------|-----------| | | | Positive | Negative | Equivocal | | Other<br>EIA | Positive | 43 | 4 | 0 | | | Negative | 0 | 107 | 0 | | | *Equivocal | 3 | 15 | 0 | | | | **95% CI | | | | Relative Sensitivity | | $43/47 = 91.5 \%$ | 79.6-97.6% | | | Relative Specificity | | $107/107 = 100.0 \%$ | 96.6-100.0% | | | Overall Agreement | | $150/154 = 97.4 \%$ | 93.5-99.3% | | | | Positive | Negative | Equivocal | | | Positive | 58 | 16 | 6 | | | Negative | 0 | 87 | 0 | | | *Equivocal | 0 | 27 | 0 | | | Relative Sensitivity | 58/74 | = 78.4 % | **95% CI<br>767.3-87.1% | | | Relative Specificity | 87/87 | = 100.0% | 95.8-100.0% | | | Overall Agreement | 145/161 | = 90.1% | 84.4-94.2% | | #### Is-anti-Cardiolipin IgM {2}------------------------------------------------ - * Equivocal results were excluded from calculations. ** 95% Confidence Intervals (CI) calculated by the Exact Method . NOTE : Please be advised that relative' refers to the comparison of the assay's on the of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgement can be made on the comparison's accuracy to predict disease. Linear regression analyses and scattergrams for the correlation studies with the comparative method are shown in FIGURES 3 and 4. Image /page/2/Figure/3 description: The image contains two scatter plots comparing two different methods. The first scatter plot, titled "FIGURE 3: Is anti-Cardiolipin IgG Correlation with Comparative Method", plots the comparative method GPL U/ml against Is-anti-Cardiolipin IgG GPL U/ml. The equation of the regression line is Y = 1.0977 + 0.8910 X, with a correlation coefficient of 0.9600 and a coefficient of determination of 0.9216. The second scatter plot, titled "FIGURE 4: Is anti-Cardiolipin IgM Correlation with Comparative Method", plots the comparative method MPL U/ml against Is-anti-cardiolipin IgM MPL U/ml, with a regression equation of Y = 1.6035 + 0.8449 X, a correlation coefficient of 0.9687, and a coefficient of determination of 0.9383. ## C. Clinical Sensitivity and Specificity A total of three hundred and fifty-four frozen retrospective, clinically characterized sera were assayed wing the A total of mree hundred and inty-four reassess both the clinical sensitivity and clines and estincity of the Is anti-Cardiding in These samples consisted of 214 normal sera, 57 sera from patients with disamotions of assay System. These samples Consisted of 214 notinal organ of themators (SE), 35 sera from patients with lipid syndrome (APS), 35 Sell from patchs with systems, polymyositisdematomyositis and theumaother autominate uiseasss suer as SJOgiors bynershop or success. Results are summarized in TABLE 3. Note that the analytical sensitivity, or limit of detection, calculated by assaying Standard A. 20 times and taking Note that the allarytical Schsirvity, or mint of economined as being 0.4 GPL or MPL U/ml. {3}------------------------------------------------ | TABLE 3 | | | | | | |------------------------------|-------|-------------------------|-------------------|-------------------------|-------------------| | | | IgG | | IgM | | | Patient Group | Total | Positive | Negative / Equiv. | Positive | Negative / Equiv. | | Normals | 214 | 1 | 213 | 3 | 211 | | APS | 57 | 47 | 10 | 27 | 30 | | SLE | 33 | 7 | 26 | 7 | 26 | | Other Autoimmune<br>Diseases | 35 | 3 | 32 | 5 | 30 | | RPR Positive | 15 | 4 | 11 | 4 | 11 | | Clinical Specificity: | | IgG | | IgM | | | | | # Neg or Equiv./Total # | | # Neg or Equiv./Total # | | | Normals | | 213/214 = 99.5% | | 211/214 = 98.5% | | | RPR Positive | | 11/15 = 73.3% | | 11/15 = 73.3% | | | Clinical Sensitivity : | | IgG | | IgM | | | | | # Pos/Total # | | # Pos/Total # | | | APS | | 47/57 = 82.5% | | 27/57 = 47.4% | | | SLE | | 7/33 = 21.2% | | 7/33 = 21.2% | | | Other Autoimmune<br>Diseases | | 3/35 = 8.6% | | 5/35 = 14.2% | | ### D. Cross Reactivity To assess the potential for positive results due to cross reactive antibition the Is antil Cardicalism Incl various autoantibodies (SSA/SSB, Scl-70, J-1, dsDNA and RF) were tested using the Is-anti-Cardiolini 2gG/Lyl various autoanthodies (SSASSB, SCF-70, Jo-1, used and one sample positive for dobby for doDNA Test Kit. In all, 36 sample were tested. One sample positive for veraining 34 samples were negative. ### E. Linearity To assess the linearity of the Is-anti-Cardiolipin IgG/IgM Test Kir several highty positive samples were serially To assess the linearity of the Is-ant-Calition was the tested in the respectively of or IDM assay systems. Repress sentative linear regression graphs and scategrams with 95% confidence intervals are presented in FIGURES 5 and 6. Image /page/3/Figure/5 description: The image contains two scatter plots, labeled as Figure 5 and Figure 6. Figure 5 shows the linearity of Is anti-Cardiolipin IgG, with the equation Y = -4.9960 + 147.5101 X. The intercept is -4.99597, the slope is 147.51010, the coefficient of determination is 0.9915, the correlation coefficient r is 0.9957, and the 95% CI for r is 0.9756 to 0.9993. Figure 6 shows the linearity of Is anti-Cardiolipin IgM, with the equation Y = 4.0837 + 87.9931 X, and the intercept is 4.08374, the slope is 87.99309, the coefficient of determination is 0.9701, the correlation coefficient r is 0.9849, and the 95% CI for r is 0.9275 to 0.9969. {4}------------------------------------------------ ### F. Correlation of Manual and MAGO Plus results The Is-anti-Cardiolipin IgG/IgM Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 172 serum samples tested for sative and of antibodies and 162 sera tested for anti-cardiolipin IgM by both the manual and automated methods were plotted. Scatter rams and regression lines of the results obtained with 95% confidence intervals mentown in FIGURES 7 and 8. The data indicate good correlation with a Correlation Coefficients (r) of 0.983 for anti-cardiolipin IgG and 0.9917 for anti-cardiolipin IgM. Image /page/4/Figure/2 description: The image contains two scatter plots comparing manual and MAGO Plus correlation for anti-Cardiolipin IgG and IgM. The left plot, labeled "FIGURE 7: Is anti-Cardiolipin IgG," shows a linear relationship with the equation Y = 1.1058 + 1.1976 X, a sample size of 172, a coefficient of determination of 0.9768, and a correlation coefficient of 0.9883. The right plot, labeled "FIGURE 8: Is anti-Cardiolipin IgM," also shows a linear relationship with the equation Y = 1.3732 + 1.1510 X, a sample size of 162, a coefficient of determination of 0.9835, and a correlation coefficient of 0.9917. With the 6-point calibration, linear regression of the IgG results showed (automated) = 1.0696 (manual) + 4.0821; with the o point date most, are 1.0174 to 1.1218 and 1.3042 to 6.8600 respectively. For gM results (automated) = 1.0169 (manual) + 2.2121; r = 0.9772. 95% CI for the slope and the intercept are 0.9824 to 1.0514 and 1.1343 to 3.2899 respectively. ### G. Precision To assess the precision of the Is anti-Cardiolipin IgG/IgM Test Kit six serum samples of varying reactivity were tested in triplicate in three separate runs. Precision was assessed both manually and using the MAGO Plus Automated EIA Processor. Precision was assessed for both IgG and IgM antibody types. The results obtained using 6-point Calibration are shown in TABLES 4-7. TABLE 4 : Manual Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgG | SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY (n=9) | | | |-------|-------------------|------|------|-------------------|------|------|-------------------|-------|-------|------------------|------|-------| | | MEAN<br>GPL | SD | CV% | MEAN<br>GPL | SD | CV% | MEAN<br>GPL | SD | CV% | MEAN<br>GPL | SD | CV% | | A | 1.6 | 0.00 | 0.00 | 1.6 | 0.06 | 3.69 | 1.6 | 0.12 | 7.07 | 1.6 | 0.07 | 4.42 | | B | 1.1 | 0.06 | 5.41 | 1.1 | 0.06 | 5.41 | 1.1 | 0.06 | 5.09 | 1.1 | 0.06 | 5.52 | | C | 17.4 | 0.45 | 2.59 | 17.6 | 1.69 | 9.63 | 18.6 | 1.53 | 8.23 | 17.9 | 1.28 | 7.17 | | D | 25.4 | 2.11 | 8.30 | 24.8 | 1.39 | 5.60 | 27.2 | 1.21 | 4.46 | 25.8 | 1.78 | 6.89 | | E | 35.3 | 0.72 | 2.05 | 29.0 | 0.58 | 1.99 | 31.2 | 1.59 | 5.10 | 31.8 | 2.92 | 9.17 | | F | 58.1 | 2.19 | 3.77 | 74.6 | 2.00 | 2.68 | 73.5 | 10.15 | 13.82 | 68.7 | 9.57 | 13.93 | TABLE 5 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgG | SERUM | INTRA-ASSAY DAY 1 | | | INTRA-ASSAY DAY 2 | | | INTRA-ASSAY DAY 3 | | | INTERASSAY (n=9) | | | |-------|-------------------|------|-------|-------------------|------|-------|-------------------|------|-------|------------------|-------|-------| | | MEAN GPL | SD | CV% | MEAN GPL | SD | CV% | MEAN GPL | SD | CV% | MEAN GPL | SD | CV% | | A | 2.5 | 0.47 | 18.90 | 3.2 | 0.58 | 17.86 | 3.9 | 1.23 | 31.51 | 3.2 | 0.95 | 29.69 | | B | 1.3 | 0.15 | 11.75 | 2.0 | 0.12 | 5.87 | 1.9 | 0.10 | 5.26 | 1.7 | 0.35 | 20.59 | | C | 29.1 | 1.15 | 3.96 | 31.8 | 1.06 | 3.33 | 40.0 | 6.32 | 15.79 | 33.6 | 5.90 | 17.56 | | D | 39.7 | 7.45 | 18.76 | 42.9 | 1.18 | 2.76 | 49.2 | 4.51 | 9.16 | 44.0 | 6.07 | 13.80 | | E | 41.5 | 0.90 | 2.16 | 45.2 | 2.68 | 5.92 | 51.5 | 1.76 | 3.41 | 46.1 | 4.69 | 10.17 | | F | 95.3 | 2.30 | 2.42 | 81.1 | 5.00 | 6.16 | 71.3 | 7.04 | 9.87 | 82.6 | 11.34 | 13.73 | {5}------------------------------------------------ TABLE 6 : Manual Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgM | SERUM | INTRA-ASSAY RUN 1 | | | INTRA-ASSAY RUN 2 | | | INTRA-ASSAY RUN 3 | | | INTERASSAY (n=9) | | | |-------|-------------------|------|-------|-------------------|------|------|-------------------|------|-------|------------------|------|-------| | | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | | A | 0.8 | 0.15 | 18.33 | 1.1 | 0.00 | 0.00 | 0.8 | 0.12 | 15.06 | 0.9 | 0.18 | 20.03 | | B | 1.1 | 0.12 | 10.19 | 1.4 | 0.00 | 0.00 | 0.9 | 0.06 | 6.19 | 1.2 | 0.21 | 18.41 | | C | 26.0 | 0.35 | 1.35 | 26.2 | 0.61 | 2.32 | 21.2 | 2.18 | 10.29 | 24.5 | 2.73 | 11.15 | | D | 35.3 | 0.53 | 1.50 | 36.1 | 1.50 | 4.17 | 31.5 | 0.85 | 2.70 | 34.3 | 2.29 | 6.67 | | E | 61.4 | 2.60 | 4.23 | 65.6 | 1.86 | 2.83 | 55.5 | 0.35 | 0.62 | 60.8 | 4.67 | 7.67 | | F | 63.3 | 3.87 | 6.11 | 65.3 | 3.23 | 4.96 | 62.6 | 2.60 | 4.16 | 63.7 | 3.08 | 4.84 | TABLE 7 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgM | SERUM | INTRA-ASSAY RUN 1 | | | INTRA-ASSAY RUN 2 | | | INTRA-ASSAY RUN 3 | | | INTERASSAY (n=9) | | | |-------|-------------------|------|-------|-------------------|------|------|-------------------|------|------|------------------|------|-------| | | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | MEAN<br>MPL | SD | CV% | | A | 2.6 | 0.25 | 9.68 | 1.9 | 0.06 | 2.99 | 1.8 | 0.06 | 3.15 | 2.1 | 0.37 | 17.62 | | B | 2.8 | 0.21 | 7.43 | 2.2 | 0.15 | 6.84 | 2.0 | 0.12 | 5.87 | 2.3 | 0.38 | 16.52 | | C | 29.4 | 2.05 | 6.98 | 30.8 | 1.30 | 4.22 | 25.0 | 0.95 | 3.79 | 28.4 | 2.95 | 10.39 | | D | 37.7 | 1.60 | 4.24 | 40.6 | 2.31 | 5.69 | 36.7 | 2.53 | 6.91 | 38.3 | 2.60 | 6.79 | | E | 65.8 | 3.25 | 4.94 | 70.4 | 0.65 | 0.92 | 59.5 | 2.81 | 4.73 | 65.2 | 5.22 | 8.01 | | F | 85.9 | 9.30 | 10.83 | 80.2 | 2.00 | 2.49 | 66.7 | 2.87 | 4.30 | 77.6 | 9.88 | 12.73 | {6}------------------------------------------------ # Expected Values The prevalence of anti-cardiolipin IgG and/or IgM antibodies may vary depending on anumber of factors such I he prevaler, geographical location, race, type of test used and clinical history of individual patients. as age, generalizar to and in absent, tace, type of two a very low incident in the normal healthy population. Increased incidence can occur in the elderly population. A published study has shown a prevacy population population. Increased includence can occur in the encorry popular on 2% for a younger population. In the encrying for addition, anti-cardiolipin antibodies were detected in 23% of elderly individuals who were also positive for anti-nuclear antibodies (13). In the present study, the expected values for a normal, healthy population were assessed by testing sera from In In the present study, the expected values to a normal, notal.of per-Cardiolipin IgC/I/DM Test Sitting both Igor one hundred and lorty-eight 3. Fronta blood dones in and forty-seven seral (99.3%) were negative for antibod ies, one serum (0.7%) was positive and none were equivocal. For IgM antibodies, and forty-six ies, one serum (0.7%) was positive and none were equivocal. The age distribution and (90.0%) weevalences for this population are shown in TABLE 8. The expected values for a clinical population were assessed by testing fifty-seven sera from patients with antibody The expected values for a Cilincal population were assessed of artify of the Arman Matthody types. Forty-seven (82.5%) were positive, nine (15.8%) were regative and one (1.7%) was equivocal for IgCly was types. Forty-seven (47.3%) were positive, twenty-nine (50.9%) were negative, and one (1.7%) was equivocal for IgM antibodies. equired to oget and antibodies are shown in FIGURES 9-12. | Total Number | Number of Donors | Prevalence | | |-------------------------|---------------------|------------|------| | | 148 | IgG | IgM | | Geographic<br>Location: | South Florida : 148 | 0.7% | 1.4% | | Age | | | | | 10-19 | 7 | 0.0% | 0.0% | | 20-29 | 36 | 0.0% | 0.0% | | 30-39 | 73 | 0.0% | 2.7% | | 40-49 | 22 | 4.5% | 0.0% | | 50-59 | 8 | 0.0% | 0.0% | | 60-69 | 2 | 0.0% | 0.0% | ### TABLE 8: Age Distribution and Prevalence of anti-Cardiolipin IgG and IgM Antibodies in a Normal S. Florida Population {7}------------------------------------------------ FIGURE 9 Distribution of anti-Cardiolipin IgG in a Normal Population FIGURE 10 Distribution of anti-Cardiolipin IgM in a Normal Population Image /page/7/Figure/2 description: This image is a histogram showing the frequency of GPL U/ml. The x-axis represents GPL U/ml, ranging from 0 to 55, while the y-axis represents frequency, ranging from 0 to 160. The histogram shows a high frequency around 0-5 GPL U/ml, with the frequency being around 140. There are also some frequencies around 45-55 GPL U/ml, but they are much lower. Image /page/7/Figure/3 description: This image is a histogram showing the frequency of MPL U/ml. The x-axis represents MPL U/ml, ranging from 0 to 18, while the y-axis represents the frequency, ranging from 0 to 100. The histogram shows that the highest frequency occurs at the lowest MPL U/ml values, with a tall bar at the beginning, and the frequency decreases as the MPL U/ml values increase. FIGURE 11 Distribution of anti-Cardiolipin IgG in a Clinical Population Image /page/7/Figure/5 description: The image shows the title of a figure. The figure is labeled as "FIGURE 12". The title of the figure is "Distribution of anti-Cardiollpin IgM in a Clinical Population". Image /page/7/Figure/6 description: This image is a histogram showing the frequency of GPL U/ml. The x-axis represents GPL U/ml, ranging from 0 to 200, while the y-axis represents frequency, ranging from 0 to 16. The histogram shows the distribution of GPL U/ml values, with the highest frequency occurring between 0 and 20, with a frequency of approximately 15. Image /page/7/Figure/7 description: The image is a histogram showing the frequency of MPL U/ml. The x-axis represents MPL U/ml, ranging from 0 to 120, while the y-axis represents frequency, ranging from 0 to 30. The histogram shows a high frequency at the lower end of MPL U/ml, with the highest frequency around 0, and a smaller peak around 100 MPL U/ml. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with a staff entwined by a serpent, representing healing and medicine. OCT 2 6 2001 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Lynne Stirling, Ph.D. Vice President, Regulatory Affairs Diamedix Corporation 2140 North Miami Avenue Miami. Florida 33127 Re: K012449 Trade/Device Name: Diamedix Is-anti-Cardiolipin IgG/IgM Test System Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MID Dated: September 28, 2001 Received: October 1, 2001 Dear Dr. Stirling: We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro rowed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as stated in the encreations of the enactment date of the Medical Device Amendments, or to conincered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). and Cosmetic Frev (110) inst the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general voltaron provisions practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I oderal statutes and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF R Fat 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by events (Sections 531-542 of the Act); 21 CFR 1000-1050. {9}------------------------------------------------ ### Page 2 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 nouncation. The I Dr Imanig of cassification 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 CFF Part 801 and II you desire specific acin vitto diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This diagliestions on the promotion and advertising of your device, (201) 594-1566. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Autman 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 {10}------------------------------------------------ ## Appendix G. Indications for Use Statement ## INDICATIONS FOR USE STATEMENT 510(K) NUMBER : _ K O/2449 # DEVICE NAME : Is anti-Cardiolipin IgG/IgMTest System Indications for Use : The Diamedix Is anti-Cardiolipin IgG/lgM Test Kit is multations for USC : The Blains (EIA) for the semi-quantitative meaan indirect enzyme immanoaocay (2.1%) in human serum as an surement of IgG or IgM antibodies to cardiolipin in human situs of Engl surement of ige of ight antiboution to the risk of thrombosis in patient with SLE or ald in the assessment of the not of the of all be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor Szusan Altaie (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K012449 For prescription Use X