(77 days)
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No
The summary describes a standard ELISA assay and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay designed to aid in the diagnosis of autoimmune disorders by detecting antibodies. It does not provide treatment or therapy.
Yes
The intended use explicitly states, "The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders," indicating its function in diagnosis.
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Jo-1 antigen in human serum," which is a laboratory test kit involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "detecting antibodies to Jo-1 antigen in a single human serum sample" and the results are to be used "as an aid in the diagnosis of autoimmune disorders." This clearly indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Jo-1 antigen in human serum." This describes a laboratory test performed on a biological sample (human serum) to measure a specific substance (IgG to Jo-1 antigen).
These points align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The assay is intended for use in detecting antibodies to Jo-1 antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
Product codes
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Device Description
The Is-anti-Jo-1 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Jo-1 antigen 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. Comparison Testing
The Diamedix Is-anti-Jo-1 Test Kit was evaluated relative to another commercially available anti-Jo-1 ELISA test kit using 100 sera from normal blood donors and 63 sera from autoimmune patients.
Relative Sensitivity: 95% (18/19) with 95% Confidence (74-100) for Manual; 95% (18/19) with 95% Confidence (84-98) for MAGO.
Relative Specificity: 99% (142/144) with 95% Confidence (95-100) for Manual; 99% (141/143) with 95% Confidence (94-100) for MAGO.
Agreement: 98% (160/163) with 95% Confidence (95-100) for Manual; 98% (159/162) with 95% Confidence (92-99) for MAGO.
One equivocal sample was excluded from the calculations for MAGO agreement.
One serum negative by Is-anti-Jo-1 (manual) and positive by the comparative method was negative when tested by a third method. Of the two sera positive by Is-anti-Jo-1 (manual) and negative by the comparative method, one was positive and one was negative when tested by a third method. One serum negative by Isanti-Jo-1 (MAGO) and positive by the comparative method was negative when tested by a third method. Of the twp sera positive by Is-anti-Jo-1 (MAGO) and negative by the comparative method, one was positive and one was negative when tested by a third method. Two of the discordant sera were from patient samples.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-Jo-1 Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Jo-1 after serial two-fold manual dilutions in Sample Diluent. Separate dilutions were tested both manually and with MAGO. The results demonstrate a high degree of linearity for the Is-anti-Jo-1 Test Kit throughout the testing range.
Manual Linearity R-squared value: 0.9962
MAGO Linearity R-squared value: 0.9911
C. Precision Testing
The precision of the Is-anti-Jo-1 Test Kit was determined at Diamedix by testing six different sera and kit controls in two runs on three different days (intra- and interassay precision).
Results shown in Table 2 for Intra-CV% and Inter-CV% for Manual and MAGO methods for various serum types (negative, positive, calibrator, controls).
D. Crossreactivity
Twenty-four sera positive for six autoimmune specificities (SSA, SSB, Sm, RNP, Jo-1, Scl-70) were tested.
Results in Table 3 show that Is-anti-Jo-1 test only showed positive results for samples with Jo-1 specificity, with other specificities yielding negative results in the Is-anti-Jo-1 EU/ml range.
E. Expected Values
The expected values in the normal population were determined by assaying 100 normal donor sera.
Figure 3 (Manual Normals) and Figure 5 (MAGO Normals) show the distribution of Jo-1 results in the normal population.
The distribution of EU/ml values for 63 clinically characterized sera along with the 100 normal donor sera is shown in Figure 4 (Manual Expected Values) and Figure 6 (MAGO Expected Values).
F. Correlation of Manual and MAGO Results
Numerical comparison of EU/ml values between manual and MAGO results for 150 samples in the Is-anti-Jo-1 Test Kit showed a correlation of 0.87 (Pearson).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 95%
Relative Specificity: 99%
Agreement: 98%
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.
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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).
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§ 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).
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510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Applicant Information:
| Date Prepared: | January 15, 1997 |
|---|---|
| Name: | Diamedix Corporation |
| Address: | 2140 N. Miami Avenue |
| Miami, FL 33127 |
| Contact Person: | Dr. Lynne Stirling |
|---|---|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |
Device Information:
| Trade Name: | Is-(immunosimplicity)-anti-Jo-1 Test System |
|---|---|
| Common Name: | Anti-Jo-1 EIA Test |
| Classification Name: | Extractable Antinuclear Antibody |
Equivalent Device:
Helix Diagnostics Enzyme Immunoassay Anti-Jo-1 Antibody Test Kit
Device Description: The Is-anti-Jo-1 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Jo-1 antigen in human serum.
Intended use: The assay is intended for use in detecting antibodies to Jo-1 antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
Comparison to Predicate Device:
The Is-anti-Jo-1 Test System is an enzyme-linked immunosorbent assay to detect IgG to Jo-1 in human serum. Purified Jo-1 antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the Jo-1 antigen are present in the patient sample, they will bind to the antigen in 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 the prior step, the substrate will be converted to produce a colored product. The reaction is stopped and the color intensity is measured photometrically providing an indirect measure of the specific antibody present in the patient sample.
1
Summary of Safety and Effectiveness
Performance Characteristics
A. Comparison Testing
The Diamedix Is-anti-Jo-1 Test Kit was evaluated relative to another commercially available anti-Jo-1 ELISA test kit using 100 sera from normal blood donors and 63 sera from autoimmune patients. The results are summarized in Table 1 below.
| Table 1 | Manual | MAGO | ||||
|---|---|---|---|---|---|---|
| Number of | ||||||
| Sera | % | 95% | ||||
| Confidence | Number of | |||||
| Sera | % | 95% | ||||
| Confidence | ||||||
| Relative | ||||||
| Sensitivity | 18/19 | 95 | 74-100 | 18/19 | 95 | 84-98 |
| Relative | ||||||
| Specificity | 142/144 | 99 | 95-100 | 141/143 | 99 | 94-100 |
| Agreement | 160/163 | 98 | 95-100 | 159/162** | 98 | 92-99 |
** One equivocal sample was excluded from the calculations.
One serum negative by Is-anti-Jo-1 (manual) and positive by the comparative method was negative when tested by a third method. Of the two sera positive by Is-anti-Jo-1 (manual) and negative by the comparative method, one was positive and one was negative when tested by a third method. One serum negative by Isanti-Jo-1 (MAGO) and positive by the comparative method was negative when tested by a third method. Of the twp sera positive by Is-anti-Jo-1 (MAGO) and negative by the comparative method, one was positive and one was negative when tested by a third method. Two of the discordant sera were from patient samples.
B. Linearity
Figures 1 and 2 show typical examples of Is-anti-Jo-1 Test Kit linearity. The figures depict the results of the Calibrator tested by Is-anti-Jo-1 after serial two-fold manual dilutions in Sample Diluent. Separate dilutions were tested both manually and with MAGO. The results demonstrate a high degree of linearity for the Is-anti-Jo-1 Test Kit throughout the testing range.
Image /page/1/Figure/9 description: The image is a graph titled "Is anti-Jo-1 Calibrator Linearity". The graph plots absorbance on the y-axis versus dilution on the x-axis. The graph shows a linear relationship between absorbance and dilution, with an R-squared value of 0.9962. The x-axis ranges from 0.0 to 1.0, while the y-axis ranges from 0.0 to 1.5.
Image /page/1/Figure/10 description: The image shows the title of a figure. The title is "Figure 1 Manual Linearity". The text is black and the background is white.
Image /page/1/Figure/11 description: The image is a graph titled "Is anti-Jo-1 Calibrator Linearity". The graph shows the relationship between absorbance and dilution. The x-axis represents dilution, ranging from 0.0 to 1.0, while the y-axis represents absorbance, ranging from 0.0 to 2.0. The R-squared value of the graph is 0.9911.
Figure 2 MAGO Linearity
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C. Precision Testing
The precision of the Is-anti-Jo-1 Test Kit was determined at Diamedix by testing six different sera and kit The problem of arrols in two runs on three different days. The intra- and interassay precision is shown in Table 2 below.
| Table 2 | anti-Jo-1 PRECISION | ||||
|---|---|---|---|---|---|
| Overall | MANUAL | MAGO | |||
| SERUM | MEAN EU/ml | INTRA-CV% | INTER-CV% | INTRA-CV % | INTER-CV % |
| 1 (NEG) | 1.8 | 9.2 | 11.1 | 13.7 | 11.1 |
| 2 (NEG) | 2.6 | 18.2 | 44.8 | 5.9 | 8.7 |
| 3 (POS) | 54.1 | 4.7 | 9.1 | 5.0 | 9.6 |
| 4 (POS) | 29.5 | 7.5 | 9.7 | 5.7 | 9.3 |
| 5 (POS) | 90.7 | 3.1 | 7.5 | 2.9 | 7.0 |
| 6 (POS) | 116.8 | 3.2 | 7.9 | 3.4 | 6.2 |
| CAL | 109.2 | 3.6 | 7.3 | 4.4 | 6.3 |
| POS CTRL | 54.5 | 3.2 | 9.2 | 2.5 | 9.7 |
| NEG CTRL | 1.5 | 12.1 | 15.4 | 28.2 | 31.3 |
D. Crossreactivity
. . . . . .
Twenty-four sera positive for the six autoimmune specificities were tested in Is- anti-Scl-70 Test Kit. The results are shown in Table 3.
| Sample | Is-anti-Jo-1 EU/ml | Interp | Specificity |
|---|---|---|---|
| 1 | 4.2 | NEG | SSA |
| 2 | 3.8 | NEG | SSA |
| 3 | 0.8 | NEG | SSA |
| 4 | 1.8 | NEG | SSA |
| 5 | 4.8 | NEG | SSB |
| 6 | 2.6 | NEG | SSB |
| 7 | 2.7 | NEG | SSB |
| 8 | 2.0 | NEG | SSB |
| 9 | 3.4 | NEG | Sm |
| 10 | 2.5 | NEG | Sm |
| 11 | 2.0 | NEG | Sm |
| 12 | 2.5 | NEG | Sm |
| 13 | 3.1 | NEG | RNP |
| 14 | 3.5 | NEG | RNP |
| 15 | 5.6 | NEG | RNP |
| 16 | 3.3 | NEG | RNP |
| 17 | 218.0 | POS | Jo-1 |
| 18 | 225.5 | POS | Jo-1 |
| 19 | 199.2 | POS | Jo-1 |
| 20 | 225.0 | POS | Jo-1 |
| 21 | 2.2 | NEG | Scl-70 |
| 22 | 3.8 | NEG | Scl-70 |
| 23 | 1.3 | NEG | Scl-70 |
| 24 | 1.5 | NEG | Scl-70 |
Table 3 Crossreactivity
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E. Expected Values
The expected values in the normal population were determined by assaying 100 normal lonor serv The expected values in the normal population were decembed of Jo-1 results in the normal population performed manually and on MAGO respectively.
The distribution of EU/ml values for 63 clinically characterized sera along with the 100 normal donor sera The disulbution of EOMIN values for collection of MAGO respectively.
Image /page/3/Figure/3 description: The image is a graph titled "Is-anti-Jo-1 Normals". The x-axis is labeled "Number of Sera" and ranges from 0 to 100. The y-axis is labeled "EU/ml" and ranges from 0.0 to 30.0. There is a horizontal line at approximately 20.0 EU/ml and a curve that increases sharply near the end of the x-axis.
Image /page/3/Figure/4 description: The image is a graph titled "Is-anti-Jo-1 Expected Values". The x-axis is labeled "Number of Sera" and ranges from 0 to 150. The y-axis is labeled "EU/ml" and ranges from 0.0 to 180.0. The graph shows a line that is relatively flat until the number of sera reaches approximately 140, at which point the line increases sharply.
Figure 3. Manual Normals
Figure 4. Manual Expected Values
Image /page/3/Figure/7 description: The image contains two plots comparing the Is-anti-Jo-1 normals and expected values. The left plot, titled "Is-anti-Jo-1 Normals," shows the distribution of values for normal samples, with the y-axis representing EU/ml and the x-axis representing the number of sera. The right plot, titled "Is-anti-Jo-1 Expected Values," shows the distribution of expected values, with a significant jump in EU/ml values after around 150 sera.
Figure 5. MAGO Normals
Figure 6. MAGO Expected Values
F. Correlation of Manual and MAGO Results
Numerical comparison of EU/ml values, between manual and MAGO results for 150 samples in the Is-anti-Jo-1 Test Kit showed a correlation of 0.87 (Pearson).