(68 days)
Not Found
No
The summary describes a standard ELISA test 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.
No.
The device is described as an aid in the diagnosis of rheumatoid arthritis by detecting specific antibodies, not for treating or preventing the disease.
Yes
The device is described as an "aid in the diagnosis of rheumatoid arthritis (RA)," which is a diagnostic purpose.
No
The device is described as a "Test Kit System" and an "enzyme-linked immunosorbent assay (ELISA)," which are inherently hardware-based laboratory tests involving reagents and physical components. While it can be used with an automated processor (MAGO® Plus), the core device itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassay as an aid in the diagnosis of rheumatoid arthritis (RA)." This describes a test performed on a sample taken from the human body (serum) to provide information for diagnostic purposes.
- Device Description: The device is described as an "enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum." ELISA is a common in vitro diagnostic technique.
- Sample Type: The test is performed on "human serum," which is a biological sample taken from the body.
- Diagnostic Aid: The test is intended to be used "as an aid in the diagnosis of rheumatoid arthritis (RA)," indicating its role in the diagnostic process.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassayas an aid in the diagnosis of rheumatoid arthritis (RA). This test kit 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)
DHR
Device Description
The Is-Rheumatoid Factor Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
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. Relative Sensitivity and Specificity versus Another EIA Test
One hundred and eighty-five frozen retrospective sera were tested using the Is-Rheumatoid Factor Test Kit and another commercially available EIA kit for detecting RF. Based upon the results of this testing the relative sensitivity, relative specificity and overall agreement were calculated. The results obtained are summarized in TABLE 1 and reveal excellent agreement with no discordant/discrepant sample results.
Relative Sensitivity = 100% (89/89)
Relative Specificity = 100% (91/91)
Overall Agreement = 100% (190/190)
B. Correlation with Nephelometry Results
Forty samples containing varying levels of RF as determined by nephelometry were tested using the Is-Rheumatoid Factor Test Kit. Samples whose results exceeded the Calibrator value were diluted and results obtained were then multipled by the dilution factor. IU/ml values determined by both methods were then subjected to linear regression analysis.
Correlation between IU/ml values determined by both methods:
Intercept = 44.8468
Slope = 1.0658
Coefficient of determination = 0.9355
Correlation coefficient r = 0.9672
95% confidence interval for r: 0.9384 to 0.9826
C. Comparison with Latex Agglutination
A total of 71 sera were tested by both methods. These consisted of 40 normal samples, 18 known clinical samples and 13 samples containing other autoantibodies with or without RF.
Normal Sera (40 samples): Latex Results 40/40 Negative, Is- Results 40/40 Negative. Specificity: Latex & Is- 100%.
Clinical Sera (18 samples): Latex Results 9/18 Positive, Is- Results 18/18 Positive. Sensitivity: Latex 50%, Sensitivity: Is- 100%.
Other Sera (13 samples): Latex Results 4/13 Positive, Is- Results 10/13 Positive. Other ELISA 9/13 Positive.
A positive result for latex at screening dilution 1:20 is considered equivalent to 60 IU/ml. All samples less than 60 IU/ml by either ELISA or nephelometry were negative by latex.
D. Linearity
Several highly positive samples were serially diluted and tested. WHO Standard and In-House Reference Standard (both assigned 100 IU/ml) were serially diluted and tested.
For WHO Standard:
Intercept = 17.8458
Slope = 90.8827
Coefficient of determination = 0.9133
Correlation coefficient = 0.9557
For In-House Standard:
Intercept = 13.0647
Slope = 95.2950
Coefficient of determination = 0.9282
Correlation coefficient r = 0.9634
E. Lack of Crossreactivity with Other Antinuclear Antibodies
RF-negative samples containing various ANAs were evaluated (5 SSA, 4 Sm, 5 RNP, 3 Scl-70, 4 Jo-1, 3 dsDNA, 1 SSB). Only one sample containing anti-SSB gave a very low positive result (21.2 IU/ml). Other samples were negative or ranged from 0.8 to 9.1 IU/ml.
F. Lack of Prozone/High-Dose Hook Effects
8 sera (4 highest concentrations, 2 mid-range, 2 negative) were tested serially diluted and undiluted. No prozone or high-dose hook effects were evidenced.
G. Correlation of Manual and MAGO Plus Results
303 normal and clinical serum samples were tested by both manual and MAGO Plus methods.
Correlation Coefficient (r) = 0.9933
Intercept = 0.0724
Slope = 1.1636
Coefficient of determination = 0.9866
95% CI for r = 0.9916 to 0.9946
H. Precision
Six serum samples of varying reactivity, kit Calibrator, and controls were tested in two runs per day for three days, both manually and using MAGO Plus.
Manual Intra-Assay and Interassay Precision (n=6 intra-assay, n=18 interassay):
Serum A (Neg) Mean: 0.8, SD: 0.16, %CV: 20.00 (Interassay)
Serum B (Neg) Mean: 0.5, SD: 0.23, %CV: 46.00 (Interassay)
Serum C (Pos) Mean: 34.5, SD: 2.08, %CV: 6.03 (Interassay)
Serum D (Pos) Mean: 58.5, SD: 2.01, %CV: 3.44 (Interassay)
Serum E (Pos) Mean: 82.2, SD: 3.23, %CV: 3.93 (Interassay)
Serum F (Pos) Mean: 99.1, SD: 3.10, %CV: 3.13 (Interassay)
Cal. Mean: 101.0, SD: 3.98, %CV: 3.94 (Interassay)
Pos. Control Mean: 43.8, SD: 2.39, %CV: 5.46 (Interassay)
Neg. Control Mean: 0.7, SD: 0.16, %CV: 22.86 (Interassay)
MAGO Plus Intra-Assay and Interassay Precision (n=6 intra-assay, n=18 interassay):
Serum A (Neg) Mean: 0.6, SD: 0.65, %CV: >50.00 (Interassay)
Serum B (Neg) Mean: 0.4, SD: 0.43, %CV: >50.00 (Interassay)
Serum C (Pos) Mean: 34.5, SD: 2.56, %CV: 7.42 (Interassay)
Serum D (Pos) Mean: 69.9, SD: 2.09, %CV: 2.99 (Interassay)
Serum E (Pos) Mean: 85.9, SD: 3.27, %CV: 3.81 (Interassay)
Serum F (Pos) Mean: 101.6, SD: 2.33, %CV: 2.29 (Interassay)
Cal. Mean: 104.7, SD: 4.21, %CV: 4.02 (Interassay)
Pos. Control Mean: 41.3, SD: 4.56, %CV: 11.04 (Interassay)
Neg. Control Mean: 0.4, SD: 0.50, %CV: >50.00 (Interassay)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity = 100%
Relative Specificity = 100%
Overall Agreement = 100%
Latex Comparison: Sensitivity (Is-) = 100%, Specificity (Is-) = 100%
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.
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
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
9 2002 JUL
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: K021394
Applicant Information:
| Date Prepared: | June 27, 2002 |
|---|---|
| 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-Rheumatoid Factor Test System |
|---|---|
| Common Name: | Rheumatoid Factor EIA Test |
| Classification Name: | RF Immunological Reagents |
Equivalent Device:
Is-RF Test System
Device Description: The Is-Rheumatoid Factor Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum.
Intended Use: The assay is intended for the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassay as an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO Plus Automated EIA processor.
Principle of the Procedure:
The Is-Rheumatoid Factor Test System is an enzyme-linked immunosorbent assay to detect RF-IgM in human serum. Purified human IgG is attached to a solid phase microtiter well. Diluted test sera are added to each well. If RF-IgM antibodies are present in the patient sample they will bind to the human IgG on the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from prior step, the reaction is stopped and the color intesnity is measured photometrically producing an indirect measure of the specific antibody present in the patient sample.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Performance Charactistics
Comparisons with Other Methods
A. Relative Sensitivity and Specificity versus Another EIA Test
One hundred and eighty-five frozen retrospective sera were tested using the Is-Rheumatoid Factor Test Kit and another commercially available EIA kit for detecting RF. Based upon the results of this testing the relative sensitivity, relative specificity and overall agreement were calculated. The results obtained are summarized in TABLE 1 and reveal excellent agreement with no discordant/discrepant sample results.
TABLE 1
| Is-Rheumatoid Factor | ||||
|---|---|---|---|---|
| Other | ||||
| EIA | Positive | Negative | *Equivocal | |
| Positive | 89 | 0 | 2 | |
| Negative | 0 | 91 | 1 | |
| * Equivocal | 2 | 0 | 0 | |
| Relative Sensitivity | ||||
| Relative Specificity | ||||
| Overall Agreement | $89/89 = 100%$ | |||
| $91/91 = 100%$ | ||||
| $190/190 = 100%$ | **95% CI | |||
| 95.9-100.0% | ||||
| 96.0-100.0% | ||||
| 98.1-100.0% |
- Equivocal results were excluded from calculations ** 95% Confidence Intervals (CI) calculated by the Exact Method (11)
B. Correlation with Nephelometry Results
Forty samples containing varying levels of RF as determined by nephelometry were tested using the Is-Rheumatoid Factor Test Kit. Samples whose results exceeded the Calibrator value were diluted and results obtained were then multipled by the dilution factor. IU/ml values determined by both methods were then subjected to linear regression analysis. The correlation between IU/ml values determined by both methods is shown below.
Image /page/1/Figure/9 description: The image is a scatter plot titled "FIGURE 1: Correlation with Nephelometry". The x-axis is labeled "Is-Rheumatoid Factor IU/ml", and the y-axis is labeled "Nephelometry IU/ml". The scatter plot shows a positive correlation between the two variables. A line of best fit is drawn through the data, and the equation of the line is "Y = 44.8468 + 1.0658 X".
Image /page/1/Figure/10 description: The image shows statistical data including the intercept, slope, coefficient of determination, correlation coefficient, and confidence interval. The intercept is 44.8468, and the slope is 1.0658. The coefficient of determination is 0.9355, and the correlation coefficient r is 0.9672. The 95% confidence interval for r ranges from 0.9384 to 0.9826.
2
C. Comparison with Latex Agglutination
The performance of the Is-Rheumatoid Factor Test Kit was also compared to that of the latex agglutination test which is another commonly used method for detecting RF. A total of 71 sera were tested by both methods. These consisted of 40 normal samples, 18 known clinical samples and 13 samples containing other autoantibodies with or without RF. The results are summarized in TABLE 2 below.
| Sample Type | # | Latex Results | Is- Results | Comments |
|---|---|---|---|---|
| Normal Sera | 40 | 40/40 Negative | 40/40 Negative | Specificity: Latex & Is- 100% |
| Clinical Sera | 18 | 9/18 Positive | 18/18 Positive | Sensitivity: Latex 50% |
| Sensitivity: Is- 100% | ||||
| Other Sera | 13 | 4/13 Positive | 10/13 Positive | Other ELISA 9/13 Positive |
| TABLE 2 : Comparison with a Latex Agglutination Test | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------ | -- |
It should be note that the screening dilution for the latex is 1:20. A positive result at this dilution is considered equivalent to 60 IU/ml. Therefore, all samples less than 60 IU/ml by either ELISA or nephelometry were negative by latex.
D. Linearity
To assess the linearity of the Is-Rheumatoid Factor Test Kit several highly positive samples were serially diluted using Sample Diluent and each dilution was then tested in the assay system. In addition to this testing, the WHO Standard anhouse Reference Standard, both assigned values of 100 IU/ml, were also serially diluted and each dilution then tested with the assay system. FIGURES 2 and 3 show the titration of these materials. The Correlation Coefficients of the other samples were in close agreement with those shown below.
Image /page/2/Figure/7 description: The image shows the title of a figure. The title is "FIGURE 2 : Linearity of WHO Standard". The text is in bold font.
Image /page/2/Figure/8 description: The image shows a scatter plot with a linear regression line. The equation of the line is Y = 17.8458 + 90.8827X. The plot shows the relationship between dilution and IU/ml. The image also includes the intercept (17.8458), slope (90.8827), coefficient of determination (0.9133), and correlation coefficient (0.9557).
Image /page/2/Figure/9 description: The image shows the title of a figure. The title is "FIGURE 3 : Linearity of In-House Standard". The title is written in a bold, sans-serif font. The text is centered on the image.
Image /page/2/Figure/10 description: The image shows a scatter plot with a linear regression line. The equation of the line is Y = 13.0647 + 95.2950 X. The plot shows the relationship between dilution and IU/ml, and the equation parameters are listed as Intercept 13.0647 and Slope 95.2950. The coefficient of determination is 0.9282, and the correlation coefficient r is 0.9634.
3
E. Lack of Crossreactivity with Other Antinuclear Antibodies
Antinuclear antibodies (ANA) have been found in 14 to 28% of patients with RA and are usually found in patients with more advanced disease (1). Several RF-negative samples (as determined by testing in an commercially available RF kit) containing various ANA were evaluated to ensure lack of interference from these antibodies in RF-negative sera. These results are shown in TABLE 3 and show that only one sample containing anti-SSB gave a very low positive result.
| # of Samples | Primary ANA
Specificity | Is-Rheumatoid Factor
IU/ml values | Interp |
|--------------|----------------------------|--------------------------------------|---------|
| 5 | SSA | 1.8, 1.9, 4.4, 1.3, 1.4 | 5/5 NEG |
| 4 | Sm | 9.1, 1.7, 1.6, 1.3 | 4/4 NEG |
| 5 | RNP | 4.0, 0.9, 1.2, 0.8, 1.6 | 5/5 NEG |
| 3 | Scl-70 | 0.8, 1.6, 3.2 | 3/3 NEG |
| 4 | Jo-1 | 1.9, 2.6, 2.7, 1.8 | 3/3 NEG |
| 3 | dsDNA | 1.6, 3.8, 3.7 | 3/4 NEG |
| 1 | SSB | 21.2 | 1/1 POS |
TABLE 3 : Crossreactivity Results
F. Lack of Prozone/High-Dose Hook Effects
The lack of interference from prozone/high-dose hook effects was determined by testing several sera, serially diluted and undiluted in the Is-Rheumatoid Factor test Kit. A total of 8 sera were evaluated, 4 contained the highest concentrations available as established by nephelometry, 2 contained levels in the mid range and 2 were in the negative range. No prozone or high-dose hook effects were evidenced by any of the results obtained from the samples tested in the assay system.
G. Correlation of Manual and MAGO Plus Results
The Is-Rheumatoid Factor Test Kit has been developed for both automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 303 normal and clinical serum samples tested for RF by both the manual and MAGO Plus methods were plotted. A scattergram and regression line of the results obtained with 95% confidence intervals is shown in FIGURE 6. The data indicate excellent correlation with a Correlation Coefficiient (r)=0.9933.
Image /page/3/Figure/8 description: This image is a scatter plot comparing MAGO Plus IU/ml to MANUAL IU/ml. The x-axis represents MANUAL IU/ml, ranging from 0 to 160, while the y-axis represents MAGO Plus IU/ml, ranging from -20 to 180. A linear regression line is plotted on the scatter plot, with the equation Y = 0.0724 + 1.1636X.
FIGURE 4 : Manual vs MAGO Plus Correlation
| Intercept = 0.0724 |
|---|
| Slope = 1.1636 |
| Coefficient of determination = 0.9866 |
| Correlation Coefficient r = 0.9933 |
| 95% CI for r = 0.9916 to 0.9946 |
4
H. Precision
To assess the precision of the Is-Rheumatoid Factor Test Kit six serum samples of varying reactivity as well as the kit Calibrator and controls were tested in two runs per day for three days. Precision was assessed both manually and using the MAGO Plus Automated EIA Processor. Results are summarized in TABLES 4 and 5.
| Intra-assay (n=6) | Interassay (n=18) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DAY 1 | DAY 2 | DAY 3 | ||||||||||
| SERUM | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV |
| A (Neg) | 0.7 | 0.21 | 30.00 | 1.0 | 0.10 | 10.00 | 0.8 | 0.05 | 6.25 | 0.8 | 0.16 | 20.00 |
| B (Neg) | 0.4 | 0.33 | >50.00 | 0.7 | 0.09 | 12.86 | 0.5 | 0.05 | 10.00 | 0.5 | 0.23 | 46.00 |
| C (Pos) | 34.1 | 1.25 | 3.67 | 35.1 | 2.94 | 8.38 | 34.2 | 1.94 | 5.67 | 34.5 | 2.08 | 6.03 |
| D (Pos) | 57.6 | 1.80 | 3.13 | 60.0 | 1.50 | 2.50 | 57.9 | 2.05 | 3.54 | 58.5 | 2.01 | 3.44 |
| E (Pos) | 82.2 | 1.93 | 2.35 | 84.9 | 3.57 | 4.20 | 79.6 | 1.57 | 1.97 | 82.2 | 3.23 | 3.93 |
| F (Pos) | 98.4 | 2.18 | 2.22 | 102.3 | 2.07 | 2.02 | 96.7 | 1.86 | 1.92 | 99.1 | 3.10 | 3.13 |
| Cal. | 98.8 | 2.03 | 2.05 | 101.6 | 1.25 | 1.23 | 98.4 | 1.16 | 1.18 | 101.0 | 3.98 | 3.94 |
| Pos. | 41.6 | 1.43 | 3.44 | 46.5 | 0.44 | 0.95 | 43.2 | 1.44 | 3.33 | 43.8 | 2.39 | 5.46 |
| Neg. | 0.7 | 0.18 | 25.71 | 0.9 | 0.05 | 5.78 | 0.6 | 0.09 | 15.00 | 0.7 | 0.16 | 22.86 |
TABLE 4 : Manual Intra-Assay and Interassay Precision for Is-Rheumatoid Factor
TABLE 5: MAGO Plus Intra-Assay and Interassay Precision for Is-Rheumatiod Factor
| Intra-assay (n=6) | Interassay (n=18) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DAY 1 | DAY 2 | DAY 3 | ||||||||||
| SERUM | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV |
| A (Neg) | 0.9 | 0.26 | 28.89 | 0.9 | 0.95 | >50.00 | 0.2 | 0.18 | >50.00 | 0.6 | 0.65 | >50.00 |
| B (Neg) | 0.3 | 0.25 | >50.00 | 0.4 | 0.40 | >50.00 | 0.4 | 0.63 | >50.00 | 0.4 | 0.43 | >50.00 |
| C (Pos) | 33.7 | 3.75 | 11.13 | 34.9 | 1.67 | 4.79 | 35.1 | 2.00 | 5.70 | 34.5 | 2.56 | 7.42 |
| D (Pos) | 69.6 | 1.18 | 1.70 | 70.3 | 3.05 | 4.34 | 69.9 | 1.96 | 2.80 | 69.9 | 2.09 | 2.99 |
| E (Pos) | 87.0 | 4.42 | 5.08 | 85.0 | 1.91 | 2.25 | 85.7 | 3.26 | 3.80 | 85.9 | 3.27 | 3.81 |
| F (Pos) | 102.0 | 1.84 | 1.80 | 101.2 | 2.52 | 2.49 | 101.6 | 2.91 | 2.86 | 101.6 | 2.33 | 2.29 |
| Cal. | 108.1 | 3.38 | 3.13 | 102.0 | 2.76 | 2.71 | 103.9 | 4.24 | 4.08 | 104.7 | 4.21 | 4.02 |
| Pos. | 43.3 | 7.29 | 16.84 | 40.5 | 2.54 | 6.27 | 40.2 | 2.02 | 5.02 | 41.3 | 4.56 | 11.04 |
| Neg. | 0.4 | 0.40 | >50.00 | 0.7 | 0.60 | >50.00 | 0.2 | 0.48 | >50.00 | 0.4 | 0.50 | >50.00 |
5
Expected Values
The prevalence of RF may vary depending on a number of factors such as age, gender, geographical location, race, type of test used and clinical history of individual patients. The expected value in the normal population is negative. However, a small but variable percentage of apparently healthy asymptomatic individuals may have RF. These individuals usually have low titers. The incidence of false positives tends to increase with age and is similar in males and females.
In the present study the expected values for a normal healthy population were assessed by testing sera from one hundred and eighteen S. Florida blood donors in the Is-Rheumatoid Factor Test Kit. One hundred and twelve sera (94.9%) were negative, two sera (1.7%) were positive and four sera (3.4%) were equivocal. The age distribution and prevalences for this population are shown in TABLE 6. Note that similar results were obtained for both manual and MAGO Plus testing.
The expected values for a clinical population were assessed by testing ninety-three sera from patients with a diagnosis of rheumatoid arthritis in the Is-Rheumatoid Factor Test Kit. For this population eighty-seven sera (93.5%) were positive, four (4.3%) were negative and two (2.2%) were equivocal.
Histograms showing the distribution of values for both the normal and clinical populations are shown in FIG-URES 5 and 6.
| Number of Donors | Prevalence | |
|---|---|---|
| Total Number | 118 | 1.69% |
| Geographic Location | South Florida : 118 | |
| Age | ||
| 10-19 | 5 | 0.0% |
| 20-29 | 25 | 4.0% |
| 30-39 | 61 | 1.6% |
| 40-49 | 20 | 0.0% |
| 50-59 | 7 | 0.0% |
TABLE 6: Age Distribution and Prevalence of Rheumatoid Factor in a Normal S. Florida Population
Image /page/5/Figure/7 description: The image contains two histograms, labeled as Figure 5 and Figure 6, which display the distribution of IgM-RF values. Figure 5 shows the distribution in a normal population, where the majority of values are concentrated near 0 IU/ml, with a frequency of approximately 100. Figure 6 illustrates the distribution in a clinical population, where the values are more spread out between 0 and 160 IU/ml, with the highest frequency of approximately 18 around 140 IU/ml.
6
Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a row and connected by flowing lines that resemble hair or fabric. The profiles are positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
9 2002 JUL
Lynne Stirling, Ph.D. Diamedix Corporation 2140 North Miami Avenue Miami, Florida 33127
Re: K021394
Trade/Device Name: Diamedix Is-Rheumatoid Factor Test System Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR Dated: May 1, 2002 Received: May 2, 2002
Dear Dr. Stirling:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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
8
Page of of
510(k) Number (if known): KOO |399
DEVICE NAME : Is-Rheumatoid Factor Test System
Indications for Use :For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassayas an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J Reeves for Sr. Altaie
(Division Sign-Off)
Division of Clinical Laboratory Devices/
510(k) Number K021394
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)