(24 days)
The Diamedix Immunosimplicity (Is) ANA ELISA ScreenTest Kit is a qualitative enzyme immunoassay intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double-stranded DNA (dsDNA and nDNA), Histones, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IF) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO Plus Automated EIA Processor.
The Is-ANA ELISA ScreenTest System is an enzyme-linked immuno-Device Description: The 15 Privated of anti-nuclear antibodies (ANA) in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Is-ANA ELISA Screen Test System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical table for the performance characteristics. Instead, it presents the results of its performance studies (relative sensitivity/specificity, clinical sensitivity/specificity, and precision) which implicitly serve as the achieved performance against an assumed set of internal or regulatory expectations.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Manual) | Reported Device Performance (MAGO Plus) |
|---|---|---|---|
| Relative Sensitivity (vs. Other ELISA Manual) | High (e.g., >90%) | 95.9% (92.1-98.2% CI) | 97.3% (93.9-99.1% CI) |
| Relative Specificity (vs. Other ELISA Manual) | High (e.g., >90%) | 95.5% (89.9-98.5% CI) | 93.8% (87.5-97.5% CI) |
| Overall Agreement (vs. Other ELISA Manual) | High (e.g., >95%) | 95.8% (92.7-97.7% CI) | 96.0% (93.1-97.9% CI) |
| Relative Sensitivity (vs. Other ELISA MAGO Plus) | High (e.g., >90%) | 96.9% (93.3-98.8% CI) | 97.9% (94.6-99.4% CI) |
| Relative Specificity (vs. Other ELISA MAGO Plus) | High (e.g., >90%) | 95.7% (90.1-98.6% CI) | 94.0% (88.0-97.5% CI) |
| Overall Agreement (vs. Other ELISA MAGO Plus) | High (e.g., >95%) | 96.4% (93.7-98.2% CI) | 96.4% (93.6-98.2% CI) |
| Clinical Specificity (Normal Sera) | High (e.g., >85%) | 89.5% (84.3-94.7% CI) | 89.2% (83.9-94.6% CI) |
| Clinical Sensitivity (Low Titer ANA+ Sera) | High (e.g., >88%) | 88.2% (72.6-96.7% CI) | 100.0% (89.7-100.0% CI) |
| Clinical Sensitivity (High Titer ANA+ Sera) | High (e.g., >90%) | 100.0% (90.0-100.0% CI) | 100.0% (90.0-100.0% CI) |
| Clinical Sensitivity (Monospecific Sera) | High (e.g., >90%) | 100.0% (92.1-100.0% CI) | 100.0% (92.0-100.0% CI) |
| Clinical Sensitivity (Autoimmune Disease Sera) | High (e.g., >90%) | 100.0% (94.9-100.0% CI) | 98.5% (91.7-100.0% CI) |
| Precision (CV% - Intra-assay & Inter-assay) | Low (e.g., <20%) | Generally <15-20% | Generally <15-20% |
| Manual vs. MAGO Plus Correlation (r) | High (e.g., >0.9) | 0.9712 | Not Applicable |
2. Sample Sizes Used for the Test Set and Data Provenance:
-
Relative Sensitivity and Specificity Comparison:
- Test Set Size: 146 sera from normal blood donors and 185 sera from clinical patients (total 331 sera). Some samples were excluded due to equivocal results, leading to slightly smaller effective sample sizes in the calculations (e.g., 308, 306, 300, 303).
- Data Provenance: Not explicitly stated (e.g., country of origin). Likely from general laboratory or donor populations relevant to the manufacturer. The data appears retrospective as existing sera were tested.
-
Clinical Sensitivity and Specificity using Characterized Sera:
- Test Set Size: 331 characterized sera, specifically:
- 146 Normal Blood Donor Sera
- 45 Monospecific Sera
- 70 IFA-ANA Positive Sera (35 low titer, 35 high titer)
- 70 Autoimmune Disease State Sera
- Data Provenance: Not explicitly stated (e.g., country of origin). "Sera obtained from a variety of sources" suggests diverse origins, but specific countries or "retrospective/prospective" are not mentioned.
- Test Set Size: 331 characterized sera, specifically:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For the Relative Sensitivity and Specificity comparison, the ground truth was established by a "comparative method" (another commercially available ANA Screen test). This implies the "expert" was the predicate device's performance, not human experts.
- For the Clinical Sensitivity and Specificity using Characterized Sera, the ground truth for normal blood donors was based on their classification as "normal." For monospecific, IFA-ANA positive, and autoimmune disease sera, the ground truth was based on pre-characterization ("known ANA reactivity" or "diagnosed with an autoimmune disorder" or "shown to be positive by the IFA-ANA method"). No mention of human experts defining these specific ground truths for the purpose of this study. The term "characterized sera" implies prior expert diagnosis or classification, but the number and qualifications of those experts are not detailed in this submission.
4. Adjudication Method for the Test Set:
- There is no explicit mention of an adjudication method involving human reviewers or a specific process like 2+1 or 3+1 for the results of the Is-ANA ELISA Screen Test Kit.
- For the relative comparison, it states samples "equivocal in either or both methods were excluded from calculations." This acts as a form of "adjudication by exclusion" rather than a consensus-based review for the equivocal cases.
- For the clinical sensitivity/specificity, the "characterized sera" were used, meaning their status was pre-determined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study evaluates an in vitro diagnostic device (IVDD) which screens for antibodies in serum. These devices are typically evaluated based on their analytical and clinical performance characteristics (sensitivity, specificity, precision) against reference methods or established patient cohorts, not by comparing human reader performance with and without AI assistance. The "AI" in this context refers to the MAGO Plus Automated EIA Processor, which is an automation system for the assay, not an AI for image interpretation or diagnosis.
6. Standalone Performance Study:
- Yes, a standalone performance study was done. The entire "Performance Characteristics" section details the standalone performance of the Is-ANA ELISA Screen Test System, both when performed manually and when run on the MAGO Plus Automated EIA Processor. This includes:
- Relative Sensitivity and Specificity (comparing it to an existing method).
- Clinical Sensitivity and Specificity (evaluating its performance against defined patient populations and known antibody reactivities).
- Precision studies.
- Correlation between manual and automated (MAGO Plus) results.
The primary goal is to show the device's ability to detect ANA.
7. Type of Ground Truth Used:
- Comparative Method Results: For relative sensitivity and specificity, the ground truth was the results obtained from "another commercially available ANA Screen test."
- Established Clinical Status/Pathology/Known Reactivity: For clinical sensitivity and specificity:
- Normal Blood Donor Sera: Implied ground truth of "absence of significant ANA" based on healthy donor status.
- Monospecific Sera: Ground truth based on known, characterized presence of "monospecific antibodies of clinical significance."
- IFA-ANA Positive Sera: Ground truth established by being "shown to be positive by the IFA-ANA method" with specified titers. IFA (Immunofluorescence Assay) is a widely accepted reference method for ANA detection.
- Autoimmune Disease State Sera: Ground truth based on patients "diagnosed with an autoimmune disorder." This is a form of clinical outcome/diagnosis ground truth.
8. Sample Size for the Training Set:
- The document does not mention a separate training set or its sample size. This type of in vitro diagnostic device typically undergoes method validation and performance studies, which don't usually involve "training sets" in the same way machine learning algorithms do. The studies described are performance evaluations, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not mentioned, the method for establishing its ground truth is not applicable in this document.
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OCT 2 5 1999
Appendix E. 510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
Name: Address:
Diamedix Corporation 2140 N. Miami Avenue Miami, FL 33127
Contact Person: Dr. Lynne Stirling Phone Number: 305-324-2354 Fax Number: 305-324-2388
000197
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance I ins summary of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ 1993299
Applicant Information:
| Date Prepared: | September 29, 1999 |
|---|---|
| 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-ANA ELISA Screen Test System |
|---|---|
| Common Name: | ANA Screening Test |
| Classification Name: | Antinuclear Antibody Immunological Test System (866.5100), product code LLL |
Equivalent Device:
Diamedix Immunosimplicity ANA (Is-ANA) Screen Test
Device Description: The Is-ANA ELISA ScreenTest System is an enzyme-linked immuno-Device Description: The 15 Privated of anti-nuclear antibodies (ANA) in human serum.
Intended Use: The assay is intended for use in detecting ANAs in human serum. The assay collectively detects in one well total ANAs against dsDNA, Histones, SSA, SSB, Sm, Sm/ contectively delects in one won tour in the agentive for IFA Hep-2 ANAs. The results of the assay can be used as an aid in the diagnosis of certain autoimmune disorders.
Principle of the Procedure:
The Is-ANA ELISA Screen Test System is an enzyme-linked immunosorbent assay to detect THE IS-ANA ELISTE SCIEON For Dysterns and other antigens extracted from the HEP-2 nucleus ANAS in human solid phase microtiter well. Diluted test sera are added to each well. If antiare attached to a sona prisos missens are present in the patient sample they will bind to the oodies winch recognize the unegels and wells are washed to remove unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody enzyme labeled anti-haman minutegrooming on the After incubation, the wells are washed to is present the only mo mates answer solution is then added to each well. If enzyme is present from prior step, the reaction is stopped and the color intensity is measured photometriprosons from pror essy are of the specific antibodies present in the patient sample.
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Performance Characteristics
A. Comparison Testing: Relative Sensitivity and Specificity
The Diamedix Is-ANA ELISA Screen Test Kit was evaluated relative to another commercially available ANA Screen test. One hundred and forty-six sera from normal blood donors and one hundred and eighty-five sera from clinical patients were tested by the Is-ANA Screen ELISA Test Kit and the comparative method. Testing by both methods was performed both manually and using the MAGO PLUS Automated EIA Processor. The results shown in Table 1 are the comparison of the Is-ANA ELISA Screen performed manually compared to the comparative method, both manual and automated. The results shown in Table 2 are the comparison of the the comparative method, ocal the MAGO Plus compared to the comparative method, both manual and automated. TABLE 1
| Is-ANA ELISA ScreenManual | Other ELISA : Manual | Other ELISA : MAGO Plus | ||||
|---|---|---|---|---|---|---|
| # of Sera | % | 95%CI | # of Sera | % | 95% CI | |
| Relative Sensitivity | 188/196 | 95.9 | 92.1-98.2 | 185/191 | 96.9 | 93.3-98.8 |
| Relative Specificity | 107/112 | 95.5 | 89.9-98.5 | 110/115 | 95.7 | 90.1-98.6 |
| Overall Agreement | 295/308* | 95.8 | 92.7-97.7 | 295/306** | 96.4 | 93.7-98.2 |
- Twenty-two samples equivocal in either or both methods were excluded from calculations; ** Twenty-one samples, equivocal in either or both methods were excluded from calculations.
| TABLﺎ- 5 | 2 |
|---|---|
| ------------------ | --- |
| Is-ANA ELISA ScreenMAGO Plus | Other ELISA : Manual | Other ELISA : MAGO Plus | ||||
|---|---|---|---|---|---|---|
| # of Sera | % | 95%CI | # of Sera | % | 95% CI | |
| Relative Sensitivity | 183/188 | 97.3 | 93.9-99.1 | 183/187 | 97.9 | 94.6-99.4 |
| Relative Specificity | 105/112 | 93.8 | 87.5-97.5 | 109/116 | 94.0 | 88.0-97.5 |
| Overall Agreement | 288/300* | 96.0 | 93.1-97.9 | 292/303** | 96.4 | 93.6-98.2 |
- Twenty-two samples equivocal in either or both methods were excluded from calculations; ** Twenty-five samples, equivocal in either or both methods were excluded from calculations.
B. Clinical Sensitivity and Specificity using Characterized Sera
A total of three hundred and thirty-one characterized sera were assayed using the Is-ANA ELISA Screen test Kit. These consisted of a number of sera of known ANA reactivity and a number of samples with no known apparent ANA reactivity. Samples tested were as follows:
a, NORMAL BLOOD DONOR SERA
One hundred and forty-six samples from normal blood donors were tested in the Is-ANA ELISA Screen. Results are shown in Table 3.
b. MONOSPECIFIC SERA
Forty-five sera obtained from a variety of sources and shown to contain monospecific antibodies of clinical significance were tested in the Is-ANA ELISA Screeen Test Kit both manually and using the MAGO Plus Automated Processor. The results are summarized in Table 3.
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b. IFA-ANA POSITIVE SERA
Seventy sera shown to be positive by the IFA- ANA method were tested in the Is-ANA ELISA Screen Test Kit. These seventy sera consisted of thirty-five sera with IFA-ANA titers between 1:40 and 1:320 and thirty-five sera with titlers in excess of 1: 320. The results obtained are summarized in Table 3.
d. AUTOIMMUNE DISEASE STATE SERA
Seventy sera from a variety of sources from patients diagnosed with an autoimmune disorder were tested both manually and on the MAGO Plus using the Is-ANA ELISA Screen. Results are shown in Table 3.
| TABLE 3 | ||||
|---|---|---|---|---|
| Patient group | Positive | Negative | Equivocal* | Total |
| a. Normal SeraManualMAGO Plus | 1414 | 119116 | 1316 | 146146 |
| b. MonospecificSeraManual &MAGO Plus | 4544 | 00 | 00 | 4544** |
| c. IFA-ANALow Titer SeraManualMAGO Plus | 3034 | 40 | 11 | 3535 |
| High Titer SeraManual &MAGO Plus | 3535 | 00 | 00 | 3535 |
| d. AutoimmuneDisease SeraManual &MAGO Plus | 7064 | 01 | 00 | 7065*** |
- Equivocal results were excluded from calculations ** one sample QNS for MAGO Plus *** Five samples QNS for MAGO Plus
| Clinical Specificity | Manual | 95% CI | MAGO Plus | 95% CI |
|---|---|---|---|---|
| Normals | 119/133 = 89.5% | 84.3-94.7 | 116/130 = 89.2% | 83.9-94.6 |
| Clinical Sensitivity | ||||
| Low Titer ANA+ Sera | 30/34 = 88.2% | 72.6-96.7 | 34/34 = 100.0% | 89.7-100.0 |
| High Titer ANA+ Sera | 35/35 = 100.0% | 90.0-100.0 | 35/35 = 100.0% | 90.0-100.0 |
| Monospecific Sera | 45/45 = 100.0% | 92.1-100.0 | 44/44 = 100.0% | 92.0-100.0 |
| Autoimmune Disease Sera | 70/70 - 100.0% | 94.9-100.0 | 64/65 = 98.5% | 91.7-100.0 |
C. Precision
The precision of the Is-ANA ELISA Screen Test Kit was determined by testing six different sera (2 negative and 4 positive) plus the kit calibrator and controls in two different runs on three different days. Precision was evaluated manally and using the MAGO PLUS Processor. The introl and internas on the manual procedure is shown in Table 4 and for the MAGO Plus Automated EIA Processor in Table S.
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| SERUM | INTRA-ASSAY DAY 1 | INTRA-ASSAY DAY 2 | INTRA-ASSAY DAY 3 | INTERASSAY | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Index | SD | CV% | Mean Index | SD | CV% | Mean Index | SD | CV% | Mean Index | SD | CV% | |
| A (NEG) | 0.262 | 0.007 | 2.7 | 0.223 | 0.024 | 10.8 | 0.280 | 0.019 | 6.8 | 0.255 | 0.030 | 11.6 |
| B (NEG) | 0.292 | 0.009 | 3.1 | 0.220 | 0.049 | 22.3 | 0.247 | 0.019 | 7.7 | 0.253 | 0.042 | 16.7 |
| C (POS) | 1.677 | 0.221 | 13.2 | 1.731 | 0.148 | 8.5 | 1.682 | 0.030 | 1.8 | 1.697 | 0.147 | 8.7 |
| D (POS) | 1.696 | 0.098 | 5.8 | 1.521 | 0.093 | 6.1 | 1.586 | 0.050 | 3.2 | 1.601 | 0.108 | 6.7 |
| E (POS) | 3.310 | 0.192 | 5.8 | 3.232 | 0.338 | 10.5 | 3.179 | 0.114 | 3.6 | 3.305 | 0.261 | 7.9 |
| F (POS) | 3.482 | 0.299 | 8.6 | 3.365 | 0.294 | 8.7 | 2.963 | 0.132 | 4.5 | 3.270 | 0.330 | 10.1 |
| c/o CAL | 1.022 | 0.068 | 6.7 | 0.992 | 0.110 | 11.1 | 0.999 | 0.121 | 12.1 | 1.004 | 0.097 | 9.6 |
| POS | 2.938 | 0.176 | 6.0 | 3.022 | 0.256 | 8.5 | 2.766 | 0.122 | 4.4 | 2.909 | 0.211 | 7.3 |
| NEG | 0.247 | 0.039 | 15.8 | 0.210 | 0.036 | 17.1 | 0.264 | 0.030 | 11.4 | 0.240 | 0.041 | 16.9 |
TABLE 4: Manual Precision
TABLE 5 : MAGO Plus Precision
| SERUM | INTRA-ASSAY DAY 1 | INTRA-ASSAY DAY 2 | INTRA-ASSAY DAY 3 | INTERASSAY | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Index | SD | CV% | Mean Index | SD | CV% | Mean Index | SD | CV% | Mean Index | SD | CV% | |
| A (NEG) | 0.377 | 0.028 | 7.4 | 0.407 | 0.052 | 12.8 | 0.395 | 0.068 | 17.2 | 0.39 | 0.051 | 12.9 |
| B (NEG) | 0.322 | 0.008 | 2.5 | 0.320 | 0.021 | 6.6 | 0.322 | 0.025 | 7.8 | 0.32 | 0.018 | 5.6 |
| C (POS) | 2.402 | 0.059 | 2.5 | 2.540 | 0.239 | 9.4 | 2.625 | 0.100 | 3.8 | 2.52 | 0.173 | 6.8 |
| D (POS) | 2.215 | 0.106 | 4.8 | 2.218 | 0.120 | 5.4 | 2.437 | 0.158 | 6.5 | 2.29 | 0.163 | 7.1 |
| E (POS) | 4.382 | 0.171 | 3.9 | 4.528 | 0.183 | 4.0 | 4.835 | 0.305 | 6.3 | 4.58 | 0.291 | 6.4 |
| F (POS) | 5.385 | 0.071 | 1.3 | 5.470 | 0.137 | 2.5 | 5.903 | 0.246 | 4.2 | 5.59 | 0.281 | 5.0 |
| c/o CAL | 0.968 | 0.053 | 5.5 | 1.025 | 0.078 | 7.6 | 1.113 | 0.055 | 4.9 | 1.04 | 0.085 | 8.2 |
| POS | 4.407 | 0.238 | 5.4 | 4.310 | 0.270 | 6.3 | 5.050 | 0.167 | 3.3 | 4.59 | 0.401 | 8.7 |
| NEG | 0.350 | 0.031 | 8.9 | 0.343 | 0.035 | 10.2 | 0.388 | 0.030 | 7.7 | 0.36 | 0.040 | 11.1 |
D. Correlation of Manual and MAGO PLUS Results
The Is-ANA ELISA Screen 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 three hundred and twenty-five serum samples tested by both methods were plotted. A scattergram and regression line of the results obtained with 95% confidence intervals is shown in FIGURE 1. The data indicate a good correlation with a correlation coefficient (r) of 0.9712.
Image /page/4/Figure/6 description: This image is a scatter plot that shows the relationship between MAGO Plus Index Values and Manual Index Values. The x-axis represents the Manual Index Values, ranging from 0 to 10, while the y-axis represents the MAGO Plus Index Values, ranging from -2 to 16. The plot shows a positive correlation between the two variables, as the MAGO Plus Index Values tend to increase with the Manual Index Values. There is a line of best fit through the data.
Image /page/4/Figure/7 description: The image is titled "FIGURE 1. Manual vs MAGO PLUS Correlation". The title is written in a bold, sans-serif font. The title is centered horizontally and vertically in the image. The image is a simple title for a figure.
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Expected Values
The expected value for a normal patient is a negative result. However, positive ANA results may be found in apparently healthy individuals. In a recent study 12.4% of sera from normal healthy donors gave a detectable ANA result . Patient sera containing autoantibodies to those antigens represented in the Is-ANA ELISA Screen Test Kit will give positive results which can be further evaluated in specific tests. The number of positive samples detected is dependent upon the populations being tested.
The expected values in a normal S. Florida blood donor population were evaluated by assaying one hundred and forty-six sera both manually and using the MAGO Plus Automated EIA Processor. Figures 2 and 4 show the distribution of results in this normal population. For manual and MAGO PLUS testing 9.6% (14/146) gave positive results. Thirteen samples (8.9%) gave equivocal results manually and sixteen samples (11.4%) gave equivocal results on the MAGO I'lus. The remainder of the samples gave negative results. Of the positive samples, three were found to contain specific autoantibodies and an additional two samples gave weakly positive IFA-ANA results.
In the present studies one-hundred and eighty-five clinical sera obtained from patients with an autoimmune disease or with a known autoantibody reactivity were also evaluated in the Is-ANA ELISA Screen Test Kit. (for MAGO Plus testing one hundred and seventy-nine were available, six being QNS). Figures 3 and 5 show the distribution of results for this positive population. For manual testing 97.2% (180/185) of samples were positive. For MAGO Plus testing 98.9% (177/179) were positive.
Image /page/5/Figure/4 description: The image contains four plots comparing expected values for normal and clinical samples using manual and MAGO Plus methods. Figure 2 shows expected values for normal samples using the manual method, with a few outliers at the end. Figure 3 shows expected values for clinical samples using the manual method, with a more gradual increase in values. Figures 4 and 5 show the same comparison using MAGO Plus, with Figure 4 showing normal samples and Figure 5 showing clinical samples.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 5 1999
Dr. Lynne Stirling Vice President, Regulatory Affairs DiaMcdix Corporation 2140 North Miami Avenue Miami, Florida 33127
Re: K993294
Trade Name: Diamedix Is-ANA ELISA Screen Test System Regulatory Class: II Product Code: LKJ Dated: September 29, 1999 Received: October 1, 1999
Dear Dr. Stirling:
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.
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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 Sutman
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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Page _ of _
10(k) Number (if known): K9932394
(Per 21 CFR 801.109)
DEVICE NAME : Is-ANA ELISA Screen Test System
Indications for Use : The Diamedix Immunosimplicity (Is) ANA ELISA ScreenTest Kit is a qualitative enzyme immunoassay intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double-stranded DNA (dsDNA and nDNA), Histones, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IF) HEp-2 ANAs. These reagents 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)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983294 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | -------------------------------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).