(492 days)
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No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI/ML terms, image processing, or data analysis methods that would suggest the use of AI/ML. The performance studies describe traditional statistical analysis of assay results.
No
The device is an in vitro diagnostic (IVD) assay designed to detect antibodies as an aid in diagnosing Systemic Lupus Erythematosus (SLE), not to treat or alleviate a disease or condition.
Yes
The device's intended use explicitly states, "The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). FOR IN VITRO DIAGNOSTIC USE." This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical laboratory assay (ELISA) involving reagents, microtiter wells, and photometric measurement, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."
- Nature of the Test: The device description details an assay performed on a single serum specimen (taken from the body) to detect antibodies. This is a classic example of an in vitro test, meaning it is performed outside of the living organism.
- Purpose: The results are intended to be used as an "aid in the diagnosis of Systemic Lupus Erythematosus (SLE)," which is a diagnostic purpose.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ribosomal P ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Ribosomal P in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). FOR IN VITRO DIAGNOSTIC USE.
Product codes
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Device Description
The Ribosomal P ELISA test is an enzyme linked immunosorbent assay to detect IgG, M, A, antibodies to Ribosomal P. Purified Ribosomal P antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman IgG, M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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
Ribosomal P ELISA test results were compared to results obtained by ouchterlony analysis of serum from clinically defined lupus (n=46) and normals (n=137).
Summary of Performance Studies
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Relative sensitivity and specificity: The Ribosomal P ELISA test results were compared to results obtained by ouchterlony analysis of serum from clinically defined lupus (n=46) and normals (n=137).
- Relative Sensitivity = 46/46 = 100% (95% Confidence Interval = 93.5%-100%)
- Relative Specificity = 136/137 = 99.3% (95% Confidence Interval = 97.8%-100%)
- Relative Agreement = 182/183 = 99.5% (95% Confidence Interval = 98.4%-100%)
- The 95% confidence interval for relative sensitivity was calculated assuming one false negative.
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Precision: The precision of the Ribosomal P kit was determined by testing seven different sera eight times each on three different assays. With proper technique the user should obtain C.V.’s of less than 15%.
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Linearity: The Ribosomal P index values were determined for serial twofold dilutions of five positive sera. The index values were compared to log2 of dilution by standard linear regression. The data indicates that the assay is semi-quantitative.
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Cross Reactivity Data: Sera containing high levels of antibodies to potentially cross reactive antigens were assayed on the Ribosomal P ELISA kit. The data indicates that antibodies to alternate autoimmune antigens do not cross react with the Ribosomal P ELISA kit.
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Prevalence: Clinical studies were conducted using 451 sera from a lupus cohort. Forty five were found to be positive for a prevalence rate of 9.98%. The data indicate that the prevalence of Ribosomal P antibody found in this cohort using the Ribosomal P device is similar to that found in the literature (12-20%).
Key Metrics
Relative Sensitivity = 46/46 = 100%
Relative Specificity = 136/137 = 99.3%
Relative Agreement = 182/183 = 99.5%
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
K950169
Summary of Safety and Effectiveness Information Ribosomal P ELISA Test Kit
MAY 2 3 1996
- I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: December 22, 1995
- ll. Description of Device
The Ribosomal P ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Ribosomal P in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). FOR IN VITRO DIAGNOSTIC USE.
The Ribosomal P ELISA test is an enzyme linked immunosorbent assay to detect IgG, M, A, antibodies to Ribosomal P. Purified Ribosomal P antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman IgG, M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
- III. Clinical Data
Clinical studies were conducted using 451 sera from a lupus cohort. Forty five were found to be positive for a prevalence rate of 9.98%. The data indicate that the prevalence of Ribosomal P antibody found in this cohort using the Ribosomal P device is similar to that found in the literature (12-20%).
1
XI. Performance Characteristics
- Relative sensitivity and specificity. The Ribosomal P ELISA test results were compared to results obtained by ouchterlony analysis of serum from clinically defined lupus (n=46) and normals (n=137). The results of the study are summarized in Table 1.
Table 1 Sensitivity and Specificity of the Ribosomal P Test Kit Relative toOuchterlony
Immuno Probe, Inc.
| Positive | Equivocal | Negative | Total | ||
|---|---|---|---|---|---|
| Ouchterlony | Positive | 46 | 0 | 0 | 46 |
| Negative | 1 | 0 | 136 | 137 | |
| Total | 47 | 0 | 136 | 183 |
| Relative Sensitivity = 46/46 = 100% | 95% Confidence Interval = 93.5%-100% |
|---|---|
| Relative Specificity = 136/137 = 99.3% | 95% Confidence Interval = 97.8%-100% |
| Relative Agreement = 182/183 = 99.5% | 95% Confidence Interval = 98.4%-100% |
The 95% confidence interval for relative sensitivity was calculated assuming one false negative.
2
2. Precision
The precision of the Ribosomal P kit was determined by testing seven different sera eight times each on three different assays The data is summarized in Table 2. With proper technique the user should obtain C. V.'s of less than 15%.
Table 2 Ribosomal P Precision Data
| Assay 1 (n=8) | Assay 2 (n=8) | Assay 3 (n=8) | Inter Assay (n=24) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Serum # | X | S.D. | C.V. | X | S.D. | C.V. | X | S.D. | C.V. | X | S.D | C.V. |
| 1 | 1.57 | 0.117 | 7.4% | 1.62 | 0.113 | 7.0% | 1.50 | 0.134 | 8.9% | 1.57 | 0.127 | 8.1% |
| 2 | 1.68 | 0.176 | 10.5% | 1.60 | 0.095 | 5.9% | 1.66 | 0.148 | 8.9% | 1.65 | 0.143 | 8.7% |
| 3 | 2.98 | 0.113 | 3.8% | 2.83 | 0.128 | 4.5% | 2.74 | 0.127 | 4.6% | 2.85 | 0.155 | 5.5% |
| 4 | 2.89 | 0.115 | 4.09% | 2.95 | 0.135 | 4.6% | 2.94 | 0.068 | 2.3% | 2.92 | 0.109 | 3.7% |
| 5 | 0.29 | 0.027 | 9.29% | 0.18 | 0.035 | 19.6% | 0.20 | 0.039 | 19.6% | 0.22 | 0.056 | 25.6% |
| 6 | 0.09 | 0.042 | 46.3% | 0.08 | 0.016 | 20.5% | 0.08 | 0.037 | 46.5% | 0.10 | 0.048 | 48.0% |
- = Mean Ribosomal P Value X
S.D. = Standard Deviation
C.V. = Coefficient of Variation
3. Linearity
The Ribosomal P index values were determined for serial twofold dilutions of five positive sera. The index values were compared to log2 of dilution by standard linear regression. The data in table # 3 indicates that the assay is semi-quantitative.
Table 3 Linearity
| Index
| Serum # | Neat | 1:2 | 1:4 | 1:8 | 1:16 | 1:32 | 1:64 | 1:128 | r |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2.70 | 2.52 | 2.24 | 1.93 | 1.57 | 1.33 | 0.98 | 0.997 | |
| 2 | 2.53 | 2.29 | 1.99 | 1.57 | 1.20 | 0.86 | 0.997 | ||
| 3 | 2.89 | 2.71 | 2.47 | 2.23 | 1.93 | 1.57 | 1.20 | 0.90 | 0.994 |
| 4 | 3.68 | 3.18 | 2.59 | 1.94 | 1.59 | 1.00 | 0.68 | 0.997 | |
| 5 | 2.09 | 1.38 | 0.94 | 0.991 |
Linear regression compared Ribosomal P Index Value to log, of dilution
3
4. Cross Reactivity Data
Sera containing high levels of antibodies to potentially cross reactive antigens were assayed on the Ribosomal P ELISA kit. The data in Table 4 indicates that antibodies to alternate autoimmune antigens do not cross react with the Ribosomal P ELISA kit.
| Serum # | Immunoprobe Index | Interpretation | Specificity |
|---|---|---|---|
| Value | |||
| 1 | 0.21 | - | Ro |
| 2 | 0.18 | - | Ro |
| 3 | 0.17 | - | Ro |
| 4 | 0.13 | - | La |
| 5 | 0.09 | - | La |
| 6 | 0.10 | - | La |
| 7 | 0.09 | - | Scl-70 |
| 8 | 0.18 | - | Scl-70 |
| 9 | 0.17 | - | Scl-70 |
| 10 | 0.15 | - | Jo-1 |
| 11 | 0.18 | - | Jo-1 |
| 12 | 0.15 | - | Jo-1 |
| 13 | 0.38 | - | Sm |
| 14 | 0.43 | - | Sm |
| 15 | 0.40 | - | Sm |
| 16 | 0.19 | - | RNP |
| 17 | 0.15 | - | RNP |
| 18 | 0.14 | - | RNP |
| 19 | 0.14 | - | DNA |
Table 4 Cross Reactivity
- Prevalence. Clinical studies were conducted using 451 sera from a lupus cohort. Forty five were found to be positive for a prevalence rate of 9.98%. The data indicate that the prevalence of Ribosomal P antibody found in this cohort using the Ribosomal P device is similar to that found in the literature (12-20%)