(143 days)
FlexSure® HP Test for Serum IgG Antibodies to H. pylori; K934863
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No
The device is described as a rapid, visually read, qualitative immunochromatographic method, which does not involve AI/ML for interpretation.
No
The device is described as a diagnostic aid for H. pylori infection, which identifies a condition but does not provide therapy or treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "for use by health professionals as an aid in the diagnosis of H. pylori infection."
No
The device description clearly states it is an "immunochromatographic method" and involves testing whole blood, indicating it is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease." This clearly indicates it's used to examine specimens derived from the human body (whole blood) to provide information for diagnostic purposes.
- Device Description: The description confirms it's a "rapid, visually read, qualitative immunochromatographic method," which is a common type of in vitro diagnostic test.
- Sample Type: The test uses "whole blood," which is a human specimen.
- Purpose: The purpose is to detect "IgG antibodies to H. pylori," which are biomarkers in the blood used to diagnose an infection.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FlexSure® HP test for IgG antibodies to H. pylori in whole blood is a rapid, visually read, qualitative immunochromatographic method. The test is for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
Product codes
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Device Description
The FlexSure® HP test for IgG antibodies to H. pylori in whole blood is a rapid, visually read, qualitative immunochromatographic method. The basic methodology and format for the FlexSure® HP Whole Blood test were established previously with the FlexSure® HP Serum test. The tests differ principally in the method for sample collection and application of the sample to the Test Card. Both tests are equally effective in determining the presence of IgG antibodies against H, pvlori.
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
health professionals
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 FlexSure® HP Whole Blood test was evaluated in a multi-center trial at six different gastroenterology clinics located in the United States, Canada and the United Kingdom. A group of 173 patients who presented with gastrointestinal symptoms were evaluated with the FlexSure® HP Whole Blood test, the FlexSure® HP Serum test and upper endoscopy where multiple biopsy specimens were studied by histology and/or a urease test.
The FlexSure® HP Whole Blood test was further evaluated in a group of 233 volunteer blood donors.
Summary of Performance Studies
The SKD FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood is substantially equivalent to the predicate device, FlexSure® HP Test for Serum IgG Antibodies to H. pylori (K934863). The performance of the FlexSure® HP whole blood product was verified by sensitivity, specificity and reproducibility and interference studies in symptomatic patients and volunteer blood donors, mainly asymptomatic individuals, not being treated for gastrointestinal disease.
Study 1: FlexSure® HP Serum Test
- Sample Size: 551 individuals (196 symptomatic and 355 asymptomatic)
- Data Source: Not specified, but comparison was with a commercial microwell ELISA serological test.
- Key Results: After eliminating 15 samples with indeterminate ELISA Values, the remaining 536 samples yielded a relative sensitivity of 95% (285/299), a relative specificity of 94% (222/237) and overall agreement of 95% (507/536). The FlexSure® HP Serum test was also compared with two other reference methods in this group of individuals: histology and 13C-urea breath test.
Study 2: FlexSure® HP Whole Blood Test (Symptomatic Patients)
- Study Type: Multi-center trial, comparison with FlexSure® HP Serum test and histology/urease test.
- Sample Size: 173 patients with gastrointestinal symptoms.
- Key Results:
- Direct comparison of the FlexSure® HP Whole Blood test with the FlexSure® HP Serum test yielded a relative sensitivity of 92%, a relative specificity of 91% and overall agreement of 92% (Table 1).
- After resolution of discordant serological results by histology and/or a urease test, the FlexSure® HP Whole Blood test had a relative sensitivity of 95%, a relative specificity of 94% and overall agreement of 95%.
- Comparison of the FlexSure® HP Whole Blood test directly with histology and/or a urease test yielded a relative sensitivity of 88%, a relative specificity of 74% and overall agreement of 82% (Table 2).
- Comparison of the FlexSure® HP Serum test with histology and/or a urease test in these patients yielded similar results: a relative sensitivity of 92%, a relative specificity of 76% and overall agreement of 84%.
Study 3: FlexSure® HP Whole Blood Test (Volunteer Blood Donors)
- Study Type: Comparison with FlexSure® HP Serum test.
- Sample Size: 233 volunteer blood donors.
- Key Results: Yielded a relative specificity of 99% and overall agreement of 97% when compared with the FlexSure® HP Serum test. Relative sensitivity could not be determined because diagnostic confirmation of H. pylori infection by a second method was not done.
Study 4: Reproducibility
- Study Type: Within- and between-site reproducibility with fresh fingerstick blood samples.
- Sample Size: Three volunteers.
- Key Results: Within-site reproducibility was 26/27 (96%) and between-site reproducibility was 24/27 (89%). Reproducibility of between-site sample sets was 9/9 for negative, 9/9 for positive and 6/9 for low/borderline positive.
Study 5: Interference
- Study Type: Evaluation for possible interference from visibly lipemic or hemolytic samples.
- Key Results: None of the biological substances tested (cholesterol, triglycerides, hemoglobin) interfered with the procedure or yielded inaccurate test results.
Study 6: Cross Reactivity
- Study Type: Evaluation of cross reactivity with various bacteria.
- Key Results: All species tested (Campylobacter jejuni, Escherichia coli, Campylobacter fetus, Helicobacter mustelae, Campylobacter coli, Helicobacter pylori) showed no cross reactivity, indicating that the test has high specificity for human antibodies against H. pylori. Helicobacter pylori was tested as a control and found to be reactive.
Key Metrics
- Relative Sensitivity:
- FlexSure® HP Serum test: 95% (285/299)
- FlexSure® HP Whole Blood vs. Serum (symptomatic, unrestored): 92%
- FlexSure® HP Whole Blood vs. Serum (symptomatic, restored): 95%
- FlexSure® HP Whole Blood vs. Histology/Urease (symptomatic): 88%
- FlexSure® HP Serum vs. Histology/Urease (symptomatic): 92%
- FlexSure® HP Whole Blood vs. Serum (volunteer blood donors): Not Determined
- Relative Specificity:
- FlexSure® HP Serum test: 94% (222/237)
- FlexSure® HP Whole Blood vs. Serum (symptomatic, unrestored): 91%
- FlexSure® HP Whole Blood vs. Serum (symptomatic, restored): 94%
- FlexSure® HP Whole Blood vs. Histology/Urease (symptomatic): 74%
- FlexSure® HP Serum vs. Histology/Urease (symptomatic): 76%
- FlexSure® HP Whole Blood vs. Serum (volunteer blood donors): 99%
- Overall Agreement:
- FlexSure® HP Serum test: 95% (507/536)
- FlexSure® HP Whole Blood vs. Serum (symptomatic, unrestored): 92%
- FlexSure® HP Whole Blood vs. Serum (symptomatic, restored): 95%
- FlexSure® HP Whole Blood vs. Histology/Urease (symptomatic): 82%
- FlexSure® HP Serum vs. Histology/Urease (symptomatic): 84%
- FlexSure® HP Whole Blood vs. Serum (volunteer blood donors): 97%
- Reproducibility:
- Within-site: 96% (26/27)
- Between-site: 89% (24/27)
Predicate Device(s)
FlexSure® HP Test for Serum IgG Antibodies to H. pylori; K934863
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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SmithKline Diagnostics, Inc.
Image /page/0/Picture/3 description: The image shows the text "JUN - 7 1988" in bold, black font. The text appears to be a date, with "JUN" representing the month of June, "7" representing the day, and "1988" representing the year. The text is slightly angled, with the right side appearing higher than the left.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
| Manufacturer: | SmithKline Diagnostics, Inc.
225 Baypointe Parkway
San Jose, CA 95134-1622
Attention: Marshall C. McCarty |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | FlexSure® HP |
| Classification Name: | Test for IgG antibodies to H. pylori in whole blood |
| Intended Use: | The FlexSure® HP test for IgG antibodies to H. pylori in
whole blood is a rapid, visually read, qualitative
immunochromatographic method. The test is for use by
health professionals as an aid in the diagnosis of H. pylori
infection in patients with clinical signs and symptoms of
gastrointestinal disease. |
| Predicate Product: | FlexSure® HP Test for Serum IgG Antibodies to H. pylori;
Manufactured by SmithKline Diagnostics, Inc. |
| Performance
Summary: | The SKD FlexSure® HP Test for IgG Antibodies to
H. pylori in Whole Blood is substantially equivalent to the
predicate device, FlexSure® HP Test for Serum IgG
Antibodies to H. pylori (K934863). The performance of the
FlexSure® HP whole blood product was verified by
sensitivity, specificity and reproducibility and interference
studies in symptomatic patients and volunteer blood donors,
mainly asymptomatic individuals, not being treated for
gastrointestinal disease. Refer to attached PERFORMANCE
CHARACTERISTICS. |
Marshall C. McCarty
Marshall C. McCarty
Marshall C. McCarty Manager, Regulatory Affairs
Facsimile: (408) 435-1953
1-il-96
Date
Date
000011
1
FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood
PERFORMANCE CHARACTERISTICS
The basic methodology and format for the FlexSure® HP Whole Blood test were established previously with the FlexSure® HP Serum test. The tests differ principally in the method for sample collection and application of the sample to the Test Card. Both tests are equally effective in determining the presence of IgG antibodies against H, pvlori.
FlexSure® HP Serum Test
】 品牌 【
The performance characteristics of the FlexSure® HP Serum test were previously reported (Premarket Notification K934863) for a group of 551 individuals (196 symptomatic and 355 asymptomatic) by comparison with a commercial microwell ELISA serological test. After eliminating 15 samples from the calculations with indeterminate ELISA Values, in accordance with the manufacturer's instructions, the remaining 536 samples yielded a relative sensitivity of 95% (285/299), a relative specificity of 94% (222/237) and overall agreement of 95% (507/536). The FlexSure® HP Serum test was also compared with two other reference methods in this group of individuals: histology and 13C-urea breath test.
FlexSure® HP Whole Blood Test
The FlexSure® HP Whole Blood test was evaluated in a multi-center trial at six different gastroenterology clinics located in the United States, Canada and the United Kingdom. A group of 173 patients who presented with gastrointestinal symptoms were evaluated with the FlexSure® HP Whole Blood test, the FlexSure® HP Serum test and upper endoscopy where multiple biopsy specimens were studied by histology and/or a urease test.
Direct comparison of the FlexSure® HP Whole Blood test with the FlexSure® HP Serum test yielded a relative sensitivity of 92%, a relative specificity of 91% and overall agreement of 92% (Table 1). After resolution of discordant serological results by histology and/or a urease test, the FlexSure® HP Whole Blood test had a relative sensitivity of 95%, a relative specificity of 94% and overall agreement of 95%.
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FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood
Table 1 FlexSure® HP Serum Test vs. FlexSure® HP Whole Blood Test Symptomatic Patients*
| FlexSure® HP Serum | |||
|---|---|---|---|
| + | - | Total | |
| FlexSure® HP | |||
| Whole Blood | 98 | 6 | 104 |
| 8 | 61 | 69 | |
| 106 | 67 | 173 | |
| Relative Sensitivity: | 92% | ||
| Relative Specificity: | 91% | ||
| Overall Agreement: | 92% |
- without resolution of discordants by histology and/or urease test
In this same group of patients, the FlexSure® HP Whole Blood test was compared directly with histology and/or a urease test, yielding a relative sensitivity of 88%, a relative specificity of 74% and overall agreement of 82% (Table 2).
Comparison of the FlexSure® HP Serum test with histology and/or a urease test in these patients yielded similar results: a relative sensitivity of 92%, a relative specificity of 76% and overall agreement of 84%.
The relative specificity of any serological test, when compared directly with histology or urease tests, may be lower if the bacterium was previously eradicated or suppressed as a result of taking antimicrobial drugs in connection with other medical treatments. In addition, sampling errors may occur due to the patchy distribution of the bacteria in the gastric mucosa. It is known that atrophy of the gastric mucosa often develops in persons with chronic active gastritis due to long-term H. pylori infection. This may lead to reduced bacterial loads making it difficult to detect the bacterium by histology or urease tests.
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FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood
Table 2 Histology and/or Urease Test vs. FlexSure® HP Whole Blood Test Symptomatic Patients
| Histology and/or Urease | |||
|---|---|---|---|
| + | - | Total | |
| FlexSure® HP | |||
| Whole Blood + | 84 | 20 | 104 |
| - | 11 | 58 | 69 |
| 95 | 78 | 173 | |
| Relative Sensitivity: | 88% | ||
| Relative Specificity: | 74% | ||
| Overall Agreement: | 82% |
The FlexSure® HP Whole Blood test was further evaluated in a group of 233 volunteer blood donors and vielded a relative specificity of 99% and overall agreement of 97%
when compared with the FlexSware UD S when compared with the FlexSure® HP Serum test. Since diagnostic confirmation of H. pylori infection by a second method was not done in this volunteer group, a meaningful determination of relative sensitivity could not be made (Table 3).
Table 3 FlexSure® HP Serum Test vs. FlexSure® HP Whole Blood Test Volunteer Blood Donors
| FlexSure® HP Serum | ||||
|---|---|---|---|---|
| + | - | Total | ||
| FlexSure® HP | ||||
| Whole Blood | + | 41 | 1 | 42 |
| - | 7 | 184 | 191 | |
| 48 | 185 | 233 | ||
| Relative Sensitivity: | Not Determined | |||
| Relative Specificity: | 99% | |||
| Overall Agreement: | 97% |
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FlexSure® HP Test for IgG Antibodies to H. pylori in Whole Blood
Reproducibility
【 上期:】
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Within- and between-site reproducibility of the FlexSure® HP Whole Blood test was done with fresh fingerstick blood samples from three volunteers with known levels of antibody to H. pylori (negative, low/borderline positive, positive). Each volunteer gave three fingerstick samples on each day of testing. The within-site reproducibility was 26/27 (96%) and the between-site reproducibility was 24/27 (89%); the reproducibility of the between-site sample sets was 9/9 for the negative, 9/9 for the positive and 6/9 for the low/borderline positive.
Interference
The FlexSure® HP Whole Blood test was evaluated for possible interference from visibly lipemic or hemolytic samples. Whole blood was obtained by venipuncture and stored in Vacutainer tubes containing EDTA. Each sample was spiked with cholesterol, triglycerides or hemoglobin to obtain concentrations above physiological levels. Blood samples that were positive or negative for IgG antibodies to H. pylori were run before and after spiking on the FlexSure® HP Whole Blood test. None of the biological substances tested interfered with the procedure or yielded inaccurate test results.
Cross Reactivity
The cross reactivity of the test was determined previously for the FlexSure® HP Serum test. Sera containing known levels of antibody against H. pylori were evaluated according to the method of Perez-Perez, et al., (Ann. Int. Med. 109:11-17, 1988) with the following bacteria:
| Campylobacter jejuni | Escherichia coli |
|---|---|
| Campylobacter fetus | Helicobacter mustelae |
| Campylobacter coli | Helicobacter pylori |
All species tested showed no cross reactivity, indicating that the test has high specificity for human antibodies against H. pylori. Helicobacter pylori was tested as a control and found to be reactive.