(132 days)
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No
The device description details a standard ELISA assay, which is a biochemical test based on antigen-antibody binding and colorimetric detection. There is no mention of AI or ML in the device description, performance studies, or any other section of the summary.
No.
This device is an In Vitro Diagnostic (IVD) assay designed to detect antibodies to a specific infection as an aid in diagnosis, not to treat or alleviate a disease or condition.
Yes
The Intended Use section states that the assay "may be used as an aid in the diagnosis of Helicobacter pylori infection".
No
The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a photometric measurement process, 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:
- Intended Use/Indications for Use: The statement "For In Vitro Diagnostic Use Only" explicitly indicates that the device is intended for use outside of the body to diagnose a condition.
- Device Description: The description details a laboratory test (ELISA) performed on a human specimen (serum) to detect antibodies, which is a characteristic of an in vitro diagnostic test.
- Purpose: The assay is used as an "aid in the diagnosis of Helicobacter pylori infection," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori antigen. The Wampole Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.
Product codes
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Device Description
The Pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori 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 is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the 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
The Pylori IgG ELISA was evaluated by masked testing 371 serum from five geographically different areas, with biopsy with stain or culture results for H. pylori. The serum were from patients with random gender and various ages with the following clinical diagnosis: gastritis, gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal.
Summary of Performance Studies
The Pylori IgG ELISA was evaluated by masked testing 371 serum from five geographically different areas, with biopsy with stain or culture results for H. pylori. The serum were from patients with random gender and various ages with the following clinical diagnosis: gastritis, gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal. Sensitivity = 244/253 = 96.4%, 95% Confidence interval = 94.1% - 98.8%. Specificity = 99/103 = 96.1%, 95% Confidence interval = 92.3% - 99.9%. Agreement = 343/356 = 96.4%, 95% Confidence interval = 94.4% - 98.3%. Equivocals were not included in the calculations. The 95% confidence intervals were calculated using the normal method.
The precision of the Pylori IgG ELISA was determined by testing six different sera ten times each on three days. The mean coefficients of variation from the intra- and interassays are presented in Table 3. Intra-assay CV ranges from 4.75% to 67.0%. Inter-assay CV ranges from 6.06% to 38.8%.
Pylori IgG ISR values were determined for paired sera from C. jujuni infections and single sera from C fetus infections. The data in Table 4 shows no rise in antibody for C. jujuni paired sera, and negative responses for C fetus infections indicating a lack of cross reactivity to these closely related organisms. Serum pairs 1, 3 and 4 demonstrate antibody to H. pylori. The pairs do not show as rise in antibody as would be expected in acute C. jujuni infection, therefore the response is considered to be specific for H. pylori with no cross reaction with C. jujuni. Sera positive for antibodies to Borrelia burgdorferi by ELISA and Western Blot were negative indicating a lack of cross reactivity. All cases diagnosed by culture, C. jejuni infection by fecal culture on Camplylobacterspecific media, C_ fetus infection by blood culture. All Borrelia burgdorferi sera were positive for antibodies by ELISA and Western Blot. Their clinical histories were suggestive of Lyme Disease.
Key Metrics
Sensitivity = 96.4%
Specificity = 96.1%
Agreement = 96.4%
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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§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
JUL 30 1996
Summary of Safety and Effectiveness Information Pylori IgG ELISA Test Kit
- I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: March 28,1995
- II. Description of Device
The Pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori antigen. The Wampole Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.
The Pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori 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 is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the 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. Predicate Device
The Pylori IgG ELISA test is substantially equivalent to biopsy. Equivalence is demonstrated by the following comparative results.
1
Performance Characteristics
A. Evaluation of Pylori IgG ELISA Sensitivity and Specificity Relative to Biopsy
The Pylori IgG ELISA is a modification of Pylori Stat. Pylori Stat was originally evaluated by masked testing 386 serum from five geographically different areas, with biopsy with stain or culture results for H. pylori. The serum were from patients with random gender and various ages with the following clinical diagnosis: gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal. Table 1 illustrates the sensitivity and specificity of Pylori Stat to Biopsy.
| Pylori Stat | |||||
|---|---|---|---|---|---|
| + | eq | - | Total | ||
| Biopsy* | + | 261 | 12 | 4 | 277 |
| - | 2 | 2 | 105 | 109 | |
| Total | 263 | 14 | 109 | 386 |
Table 1 Pylori Stat IgG ELISA Sensitivity and Specificity
| Sensitivity = 261/265 = 98.5% | 95% Confidence interval = 97.0% - 100% |
|---|---|
| Specificity = 105/107 = 98.1% | 95% Confidence interval = 95.5% - 100% |
| Agreement = 366/372 = 98.4% | 95% Confidence interval = 97.1% - 99.7% |
- Culture or stain
Equivocals were not included in the above calculations.
The 95% confidence intervals were calculated using the normal method.
2
The Pylori IgG ELISA was evaluated by masked testing 371 serum from five geographically different areas, with biopsy with stain or culture results for H. pylori. The serum were from patients with random gender and various ages with the following clinical diagnosis: gastritis, gastric ulcer, duodenal ulcer, non-ulcer dyspepsia, esophagitis and normal. Table 2 illustrates the sensitivity and specificity of Pylori IgG ELISA to Biopsy.
Table 2
Pylori IgG ELISA Relative Sensitivity and Specificity
Wampole Pylori IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| + | 244 | 13 | 9 | 266 | |
| Biopsy* | - | 4 | 2 | 99 | 105 |
| Total | 248 | 15 | 108 | 371 |
| Sensitivity = 244/253 = 96.4% | 95% Confidence interval = 94.1% - 98.8% |
|---|---|
| Specificity = 99/103 = 96.1% | 95% Confidence interval = 92.3% - 99.9% |
| Agreement = 343/356 = 96.4% | 95% Confidence interval = 94.4% - 98.3% |
- Culture or stain positive
Equivocals were not included in the above calculations.
The 95% confidence intervals were calculated using the normal method.
3
B. Evaluation of Pylori IgG ELISA Precision
The precision of the Pylori IgG ELISA was determined by testing six different sera ten times each on three days. The mean coefficients of variation from the intra- and interassays are presented in Table 3
Table 3 Pylori IgG ELISA Precision
| Assay 1 (n=10) | Assay 2 (n=10) | Assay 3 (n=10) | InterAssay (n=30) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| X | SD | CV | X | SD | CV | X | SD | CV | X | SD | CV | |
| 1 | 3.13 | 0.209 | 6.68% | 3.05 | 0.145 | 4.75% | 3.13 | 0.210 | 6.71% | 3.10 | 0.188 | 6.06% |
| 2 | 2.08 | 0.151 | 7.26% | 2.15 | 0.156 | 7.26% | 2.01 | 0.127 | 6.32% | 2.08 | 0.151 | 7.26% |
| 3 | 2.31 | 0.258 | 11.2% | 2.29 | 0.115 | 5.02% | 2.24 | 0.173 | 7.72% | 2.28 | 0.187 | 8.20% |
| 4 | 1.17 | 0.184 | 15.7% | 1.47 | 0.148 | 10.1% | 1.30 | 0.179 | 13.8% | 1.31 | 0.207 | 15.8% |
| 5 | 0.06 | 0.018 | 30.0% | 0.12 | 0.014 | 11.7% | 0.11 | 0.056 | 50.9% | 0.08 | 0.031 | 38.8% |
| 6 | 0.10 | 0.016 | 16.0% | 0.14 | 0.020 | 14.3% | 0.10 | 0.067 | 67.0% | 0.12 | 0.023 | 19.2% |
C. Evaluation of Pylori IgG ELISA with Potentially Cross Reactive Sera.
Pylori IgG ISR values were determined for paired sera from C. jujuni infections and single sera from C fetus infections. The data in Table 4 shows no rise in antibody for C. jujuni paired sera, and negative responses for C fetus infections indicating a lack of cross reactivity to these closely related organisms. Serum pairs 1, 3 and 4 demonstrate antibody to H. pylori. The pairs do not show as rise in antibody as would be expected in acute C. jujuni infection, therefore the response is considered to be specific for H. pylori with no cross reaction with C. jujuni. Sera positive for antibodies to Borrelia burgdorferi by ELISA and Western Blot were negative indicating a lack of cross reactivity.
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Table 4 Pylori IgG Results with Potentially Cross-reactive Sera
| Serum # | Diagnosis* | Pylori IgG ISE |
|---|---|---|
| Acute 1 | ||
| Convalescent 1 | C. jejuni Diarrhea | 2.30 |
| 2.41 | ||
| Acute 2 | ||
| Convalescent 2 | C. jejuni Diarrhea | 2.11 |
| 2.23 | ||
| Acute 3 | ||
| Convalescent 3 | C. jejuni Diarrhea | 1.23 |
| 1.20 | ||
| Acute 4 | ||
| Convalescent 4 | C. jejuni Diarrhea | 0.40 |
| 0.57 | ||
| Acute 5 | ||
| Convalescent 5 | C. jejuni Diarrhea | 0.88 |
| 0.89 | ||
| 6 | C. fetus Endocarditis | 0.59 |
| 7 | C. fetus Endocarditis | 0.63 |
| 8 | C. fetus Endocarditis | 0.72 |
| 9 | C. fetus Bacteremia | 0.38 |
- All cases diagnosed by culture, C. jejuni infection by fecal culture on Camplylobacterspecific media, C_ fetus infection by blood culture.
| 10. | Borrelia burgdorferi | 0.44 |
|---|---|---|
| 11. | Borrelia burgdorferi | 0.20 |
| 12. | Borrelia burgdorferi | 0.22 |
| 13. | Borrelia burgdorferi | 0.89 |
| 14. | Borrelia burgdorferi | 0.11 |
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| 15. | Borrelia burgdorferi | 0.20 |
|---|---|---|
| 16. | Borrelia burgdorferi | 0.16 |
| 17. | Borrelia burgdorferi | 0.59 |
| 18. | Borrelia burgdorferi | 0.09 |
| 19. | Borrelia burgdorferi | 0.13 |
All Borrelia burgdorferi sera were positive for antibodies by ELISA and Western Blot. Their clinical histories were suggestive of Lyme Disease
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