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K Number
K012449
Device Name
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
Manufacturer
DIAMEDIX CORP.
Date Cleared
2001-10-26

(86 days)

Product Code
MID
Regulation Number
866.5660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
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
More Information

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No
The summary describes a standard enzyme immunoassay (ELISA) kit and an automated processor. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies focus on traditional analytical and clinical validation metrics for an immunoassay.

No
This device is an in vitro diagnostic (IVD) test kit used for the semi-quantitative measurement of antibodies to cardiolipin, which aids in risk assessment for thrombosis. It does not provide therapy or treatment to a patient.

Yes

The Intended Use section clearly states that the device is "for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders," which is a diagnostic purpose.

No

The device is a test kit (ELISA) which is a physical product used to perform a laboratory assay. While it can be used with an automated processor (MAGO Plus), the core device itself is a hardware-based diagnostic test.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders." This describes a test performed on a sample taken from the human body (serum) to provide information about a medical condition (risk of thrombosis in patients with SLE or SLE-like disorders).
  • Device Description: The "Device Description" further clarifies that it is an "enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum." This confirms it's a laboratory test performed on a biological sample.
  • Performance Studies: The detailed descriptions of performance studies involving testing human serum samples (normal sera, sera from patients with various conditions) are characteristic of the validation required for IVD devices.
  • Predicate Device: The mention of a "Predicate Device" (Orgentec Anti-cardiolipin ELISA Assay) is common in regulatory submissions for IVD devices, where a new device is compared to an already approved device.

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patients with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Product codes (comma separated list FDA assigned to the subject device)

MID

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A. 3-point vs 6-point calibration

  • Study Type: Equivalence of calibration methods.
  • Sample Size: 172 samples (IgG), 193 samples (IgM).
  • Key Results: Linear regression analysis showed good correlation.
    • IgG: Y = 2.4036 + 0.9996X, correlation coefficient of 0.9861.
    • IgM: Y = 0.5333 + 0.9411X, correlation coefficient of 0.9925.

B. Relative Sensitivity and Specificity

  • Study Type: Comparison with a commercially available ELISA kit.
  • Sample Size: 172 frozen retrospective sera (IgG), 194 frozen retrospective sera (IgM).
  • Key Results:
    • Anti-cardiolipin IgG:
      • Relative Sensitivity: 43/47 = 91.5% (95% CI: 79.6-97.6%)
      • Relative Specificity: 107/107 = 100.0% (95% CI: 96.6-100.0%)
      • Overall Agreement: 150/154 = 97.4% (95% CI: 93.5-99.3%)
      • Discordant samples resolved: 4 negative in Is-anti-Cardiolipin IgG but positive by other EIA were also negative by a referee EIA method.
    • Is-anti-Cardiolipin IgM:
      • Relative Sensitivity: 58/74 = 78.4% (95% CI: 767.3-87.1%)
      • Relative Specificity: 87/87 = 100.0% (95% CI: 95.8-100.0%)
      • Overall Agreement: 145/161 = 90.1% (95% CI: 84.4-94.2%)
      • Discordant samples resolved: Of 16 negative in Is-anti-Cardiolipin IgM but positive in other EIA, 13 were negative and 3 were positive by a referee method.
    • Linear regression analyses for correlation shown in Figures 3 and 4:
      • IgG: Y = 1.0977 + 0.8910 X, correlation coefficient of 0.9600.
      • IgM: Y = 1.6035 + 0.8449 X, correlation coefficient of 0.9687.

C. Clinical Sensitivity and Specificity

  • Study Type: Assessment using clinically characterized sera.
  • Sample Size: 354 frozen retrospective sera (214 normal, 57 APS, 33 SLE, 35 Other Autoimmune Diseases, 15 RPR Positive).
  • Key Results:
    • Clinical Specificity (IgG):
      • Normals: 213/214 = 99.5%
      • RPR Positive: 11/15 = 73.3%
    • Clinical Specificity (IgM):
      • Normals: 211/214 = 98.5%
      • RPR Positive: 11/15 = 73.3%
    • Clinical Sensitivity (IgG):
      • APS: 47/57 = 82.5%
      • SLE: 7/33 = 21.2%
      • Other Autoimmune Diseases: 3/35 = 8.6%
    • Clinical Sensitivity (IgM):
      • APS: 27/57 = 47.4%
      • SLE: 7/33 = 21.2%
      • Other Autoimmune Diseases: 5/35 = 14.2%
    • Analytical sensitivity (limit of detection): 0.4 GPL or MPL U/ml.

D. Cross Reactivity

  • Study Type: Assessment for potential positive results due to cross-reactive antibodies.
  • Sample Size: 36 samples tested with various autoantibodies (SSA/SSB, Scl-70, Jo-1, dsDNA, RF).
  • Key Results: One sample positive for dsDNA showed cross-reactivity (positive result with low concentration), remaining 34 samples were negative.

E. Linearity

  • Study Type: Assessment of linearity using serially diluted highly positive samples.
  • Key Results: Representative linear regression graphs and scattergrams (Figures 5 and 6) showed good linearity.
    • IgG: Y = -4.9960 + 147.5101 X, correlation coefficient r = 0.9957 (95% CI: 0.9756 to 0.9993).
    • IgM: Y = 4.0837 + 87.9931 X, correlation coefficient r = 0.9849 (95% CI: 0.9275 to 0.9969).

F. Correlation of Manual and MAGO Plus results

  • Study Type: Demonstration of equivalence between manual and automated (MAGO Plus) methods.
  • Sample Size: 172 serum samples (IgG), 162 sera (IgM).
  • Key Results: Good correlation with correlation coefficients (r) of 0.983 for anti-cardiolipin IgG and 0.9917 for anti-cardiolipin IgM.
    • IgG (automated) = 1.0696 (manual) + 4.0821; r = 0.9768 (with 6-point calibration), slope CI: 1.0174 to 1.1218, intercept CI: 1.3042 to 6.8600.
    • IgM (automated) = 1.0169 (manual) + 2.2121; r = 0.9772, slope CI: 0.9824 to 1.0514, intercept CI: 1.1343 to 3.2899.

G. Precision

  • Study Type: Intra-assay and interassay precision assessment.
  • Sample Size: Six serum samples of varying reactivity, tested in triplicate in three separate runs.
  • Key Results: Precision assessed manually and using MAGO Plus. (Detailed results in Tables 4-7, showing Mean, SD, CV%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Relative Sensitivity and Specificity (compared to another commercially available ELISA kit):

  • Is-anti-Cardiolipin IgG:
    • Relative Sensitivity: 91.5%
    • Relative Specificity: 100.0%
    • Overall Agreement: 97.4%
  • Is-anti-Cardiolipin IgM:
    • Relative Sensitivity: 78.4%
    • Relative Specificity: 100.0%
    • Overall Agreement: 90.1%

Clinical Sensitivity and Specificity:

  • IgG Clinical Specificity:
    • Normals: 99.5%
    • RPR Positive: 73.3%
  • IgM Clinical Specificity:
    • Normals: 98.5%
    • RPR Positive: 73.3%
  • IgG Clinical Sensitivity:
    • APS: 82.5%
    • SLE: 21.2%
    • Other Autoimmune Diseases: 8.6%
  • IgM Clinical Sensitivity:
    • APS: 47.4%
    • SLE: 21.2%
    • Other Autoimmune Diseases: 14.2%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Orgentec Anti-cardiolipin ELISA Assay

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).

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
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
PositiveNegativeEquivocal
Other
EIAPositive4340
Negative01070
*Equivocal3150
**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%
PositiveNegativeEquivocal
Positive58166
Negative0870
*Equivocal0270
Relative Sensitivity58/74= 78.4 %**95% CI
767.3-87.1%
Relative Specificity87/87= 100.0%95.8-100.0%
Overall Agreement145/161= 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
IgGIgM
Patient GroupTotalPositiveNegative / Equiv.PositiveNegative / Equiv.
Normals21412133211
APS5747102730
SLE33726726
Other Autoimmune
Diseases35332530
RPR Positive15411411
Clinical Specificity:IgGIgM
# Neg or Equiv./Total ## Neg or Equiv./Total #
Normals213/214 = 99.5%211/214 = 98.5%
RPR Positive11/15 = 73.3%11/15 = 73.3%
Clinical Sensitivity :IgGIgM
# Pos/Total ## Pos/Total #
APS47/57 = 82.5%27/57 = 47.4%
SLE7/33 = 21.2%7/33 = 21.2%
Other Autoimmune
Diseases3/35 = 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

SERUMINTRA-ASSAY DAY 1INTRA-ASSAY DAY 2INTRA-ASSAY DAY 3INTERASSAY (n=9)
MEAN
GPLSDCV%MEAN
GPLSDCV%MEAN
GPLSDCV%MEAN
GPLSDCV%
A1.60.000.001.60.063.691.60.127.071.60.074.42
B1.10.065.411.10.065.411.10.065.091.10.065.52
C17.40.452.5917.61.699.6318.61.538.2317.91.287.17
D25.42.118.3024.81.395.6027.21.214.4625.81.786.89
E35.30.722.0529.00.581.9931.21.595.1031.82.929.17
F58.12.193.7774.62.002.6873.510.1513.8268.79.5713.93

TABLE 5 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgG

SERUMINTRA-ASSAY DAY 1INTRA-ASSAY DAY 2INTRA-ASSAY DAY 3INTERASSAY (n=9)
MEAN GPLSDCV%MEAN GPLSDCV%MEAN GPLSDCV%MEAN GPLSDCV%
A2.50.4718.903.20.5817.863.91.2331.513.20.9529.69
B1.30.1511.752.00.125.871.90.105.261.70.3520.59
C29.11.153.9631.81.063.3340.06.3215.7933.65.9017.56
D39.77.4518.7642.91.182.7649.24.519.1644.06.0713.80
E41.50.902.1645.22.685.9251.51.763.4146.14.6910.17
F95.32.302.4281.15.006.1671.37.049.8782.611.3413.73

5

TABLE 6 : Manual Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgM

SERUMINTRA-ASSAY RUN 1INTRA-ASSAY RUN 2INTRA-ASSAY RUN 3INTERASSAY (n=9)
MEAN
MPLSDCV%MEAN
MPLSDCV%MEAN
MPLSDCV%MEAN
MPLSDCV%
A0.80.1518.331.10.000.000.80.1215.060.90.1820.03
B1.10.1210.191.40.000.000.90.066.191.20.2118.41
C26.00.351.3526.20.612.3221.22.1810.2924.52.7311.15
D35.30.531.5036.11.504.1731.50.852.7034.32.296.67
E61.42.604.2365.61.862.8355.50.350.6260.84.677.67
F63.33.876.1165.33.234.9662.62.604.1663.73.084.84

TABLE 7 : MAGO Plus - Intra-Assay and Interassay Precision for Is-anti-Cardiolipin IgM

SERUMINTRA-ASSAY RUN 1INTRA-ASSAY RUN 2INTRA-ASSAY RUN 3INTERASSAY (n=9)
MEAN
MPLSDCV%MEAN
MPLSDCV%MEAN
MPLSDCV%MEAN
MPLSDCV%
A2.60.259.681.90.062.991.80.063.152.10.3717.62
B2.80.217.432.20.156.842.00.125.872.30.3816.52
C29.42.056.9830.81.304.2225.00.953.7928.42.9510.39
D37.71.604.2440.62.315.6936.72.536.9138.32.606.79
E65.83.254.9470.40.650.9259.52.814.7365.25.228.01
F85.99.3010.8380.22.002.4966.72.874.3077.69.8812.73

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 NumberNumber of DonorsPrevalence
148IgGIgM
Geographic
Location:South Florida : 1480.7%1.4%
Age
10-1970.0%0.0%
20-29360.0%0.0%
30-39730.0%2.7%
40-49224.5%0.0%
50-5980.0%0.0%
60-6920.0%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.

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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

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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