(89 days)
Not Found
No
The device description details a rapid membrane enzyme immunoassay with visual interpretation of results, and there is no mention of AI or ML in the document.
No.
The device is used to detect an H. pylori antigen to aid in diagnosis and to confirm loss of the antigen after treatment. It does not provide therapy itself.
Yes
The intended use explicitly states that the device is "to aid in the diagnosis of H. pylori infection."
No
The device description clearly outlines a physical test kit involving a membrane device, reagents (diluent, conjugate, wash buffer, substrate), and a visual examination of the reaction window. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "qualitative detection of Helicobacter pylori specific antigen in a single use cassette" using "human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment." This clearly indicates it is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a test that utilizes antibodies and chemical reactions to detect a specific analyte (H. pylori antigen) in a biological sample (fecal specimen). This is a hallmark of in vitro diagnostic tests.
- Anatomical Site: The test uses "Human fecal specimens," which are samples taken from the human body.
- Intended User / Care Setting: It is listed as "Prescription Use" and the results are to be "taken into consideration by the physician," indicating it is used in a healthcare setting for diagnostic purposes.
- Performance Studies: The document includes detailed performance studies evaluating the device's sensitivity, specificity, and agreement with reference methods, which are standard requirements for demonstrating the performance of an IVD.
- Predicate Device: A predicate device (ImmunoCard STAT!® HpSA) is listed, which is another IVD for H. pylori detection. This further supports the classification of this device as an IVD.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
Product codes (comma separated list FDA assigned to the subject device)
LYR
Device Description
The H. PYLORI QUIK CHEK™ test utilizes antibodies specific for H. pylori antigen. The Membrane Device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies specific for H, pylori antigen. The ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any H. pylori antigen in the sample binds to the antibody-peroxidase conjugate. The antigen-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-H. pylori antigen antibodies in the test line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "C" and "T" sides of the Reaction Window. A blue line on the "T" side of the Reaction Window indicates a positive result. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human fecal specimens
Indicated Patient Age Range
The ages ranged from 19 to 82 years.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D), physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The performance of the H. PYLORI QUIK CHEK™ test was evaluated at 6 independent sites. Patients were recruited that were undergoing endoscopy as part of routine care. A composite reference method (CRM) comparison was used in the evaluation consisting of rapid urease and histology of the biopsy samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the H. PYLORI QUIK CHEK™ test was evaluated at 6 independent sites. Patients were recruited that were undergoing endoscopy as part of routine care. A composite reference method (CRM) comparison was used in the evaluation consisting of rapid urease and histology of the biopsy samples. The results of the study show that the H. PYLORI QUIK CHEK™ test exhibited a sensitivity of 97.0% and specificity 100% with CRM biopsy results.
Initial Diagnosis H. PYLORI QUIK CHEK™ test versus Composite reference Method (CRM)
N = 122 patients. CRM Positive: 33, CRM Negative: 89. H. PYLORI QUIK CHEK™ Positive: 32 (CRM Positive), 0 (CRM Negative). H. PYLORI QUIK CHEK™ Negative: 1* (CRM Positive), 89 (CRM Negative).
*Additional testing with an FDA cleared H. pylori stool antigen test provided an antigen negative result.
Post-Therapy
N = 9 samples from patients being tested post therapy. CRM Positive: 9, CRM Negative: 0. H. PYLORI QUIK CHEK™ Positive: 9 (CRM Positive), 0 (CRM Negative). H. PYLORI QUIK CHEK™ Negative: 0 (CRM Positive), 0 (CRM Negative).
Retrospective Sample Study
A supplemental retrospective sample study was performed comparing the H. PYLORI QUIK CHEK™ test to an FDA cleared commercial ELISA. For this study, 200 samples (94 positive and 106 negative by the commercial ELISA). There was 98.9% Positive Agreement and 97.2% Negative Agreement of results between the assays.
N = 200. FDA Cleared Commercial ELISA Positive: 94, FDA Cleared Commercial ELISA Negative: 106. H. PYLORI QUIK CHEK™ Positive: 93 (Commercial ELISA Positive), 3* (Commercial ELISA Negative). H. PYLORI QUIK CHEK™ Negative: 1** (Commercial ELISA Positive), 103 (Commercial ELISA Negative).
*H. pylori DNA was amplified from the samples with PCR
**No H. pylori DNA was amplified from the sample with PCR
Reproducibility
The reproducibility of the H. PYLORI QUIK CHEK™ test was determined using 8 fecal specimens that were coded to prevent identification during testing. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The samples were tested in triplicate twice a day over a 5day period by multiple technicians at each site using 2 different kit lots. The results were as expected among the different locations, and exhibited an overall percent agreement of 100%.
Analytical Sensitivity
The Limit of Detection (LoD) for the H. PYLORI QUIK CHEK™ test was established at 16.08 ng/ml. in fecal matrix (0.24 ng/test) for Helicobacter pylori antigen using cell lysate antigen prepared from H. pylori strain ATCC 43526. For specimens in Protocol™ Cary Blair media, the LoD was established at 13.01 ng/mL (0.20 ng/test). For specimens in Protocol™ C&S media, the LoD was established at 19.96 ng/mL (0.31 ng/test).
Analytical Specificity (Cross Reactivity)
The H. PYLORI QUIK CHEK™ test was evaluated for cross-reactivity with common intestinal organisms and viruses listed. None of the organisms or viruses were shown to interfere with the performance of the H. PYLORI QUIK CHEK™ test.
Inclusivity Study
The strains ATCC 700392, JP26, ATCC 43526, ATCC 43504, ATCC 700824, and ATCC 43579 were tested for reactivity with H. PYLORI QUIK CHEK™ test. All strains tested generated a positive result.
Interfering Substances (U.S. Formulation)
Barium sulfate (5% w/v), Benzalkonium Chloride (1% w/v), Ciprofloxacin (0.25% w/v), Ethanol (1% w/v), Hog gastric mucin (3.5% w/v), Human blood (40% v/v), Hydrocortisone (1% w/v), Imodium® (5% v/v), Kaopectate® (5% v/v), Leukocytes (0.05% v/v), Maalox® Advanced (5% v/v), Mesalazine (10% w/v), Metronidazole (0.25% w/v), MiraLax® (3350 PEG)(7% w/v), Mineral Oil (10% w/v), Mylanta® (4.2 mq/mL), Naproxen Sodium (5% w/v), Nonoxynol-9 (1% w/v), Palmitic Acid/Fecal Fat (40% w/v), Pepto-Bismo® (5% v/v), Phenvlephrine (1% w/v), Prilosec OTC® (5 µg/mL), Sennosides (1% w/v), Simethicone (10% w/v), Stearic Acid/Fecal Fat (40% w/v), Tagamet® (5 ug/mL), TUMS® (50 µg/mL), Human Urine (5% v/v), and Vancomycin (0.25% w/v) had no effect on positive H. PYLORI QUIK CHEK™ test results analyzed at the concentrations indicated.
Prozone
There was no overall prozone effect that elevated levels of antigen did not affect the detection of the antigen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Initial Diagnosis:
Sensitivity: 97.0% (95% Confidence Limits: 84.7% - 99.5%)
Specificity: 100.0% (95% Confidence Limits: 95.9% - 100.0%)
Post-Therapy:
Sensitivity: 100.0% (95% Confidence Limits: 70.1% - 100.0%)
Retrospective Sample Study:
Percent Positive Agreement: 98.9% (95% Confidence Limits: 94.2% - 99.8%)
Percent Negative Agreement: 97.2% (95% Confidence Limits: 92.0% - 99.0%)
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
August 21, 2018
TECHLAB. Inc. Donna Link Director Regulatory and Compliance 2001 Kraft Drive Corporate Research Center Blacksburg, Virginia 24060-6358
Re: K181379
Trade/Device Name: H. Pylori Quik Chek Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR Dated: May 23, 2018 Received: May 24, 2018
Dear Donna Link:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181379
Device Name H. PYLORI QUIK CHEK
Indications for Use (Describe)
The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
H. PYLORI QUIK CHEK™ 510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant/Contact Information:
| Date Prepared: | August 16, 2018 |
|---|---|
| Name: | TECHLAB, Inc. |
| Address: | 2001 Kraft Drive |
| Corporate Research Center | |
| Blacksburg, VA 24060 USA |
| Contact Person: | Donna T. Link |
|---|---|
| Phone Number: | 540-953-1664 |
| Email: | dlink@techlab.com |
1.1 Manufacturing Facility Address
TECHLAB, Inc. 20 Corporate Drive Radford, VA 24141 USA
1.2 Product and Trade Name of the Device
H. PYLORI QUIK CHEK™
1.3 Common Name or Classification Name
H. pylori detection test
1.4 Classification and Regulation
Class I 21 CFR 866.3110; Campylobacter fetus serological reagents
1.5 Product Code
LYR – Campylobacter pylori
1.6 Panel
83 Microbiology
1.7 Reason for Premarket Notification
The development of a new rapid membrane enzyme immunoassay for the qualitative detection of H. pylori in a single use cassette.
4
Intended Use
The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician
Explanation
It is estimated that half of the global population is infected with H. pylori. The majority of those infected remain asymptomatic and do not require treatment (colonized individuals). A minority of infected individuals develop gastritis, and a fraction of those further develop gastric ulcers or gastric cancer. The diagnosis of H. pylori infection is endoscopy with biopsy - the biopsied tissue is tested for the presence of H. pylori by culture, histology, or rapid urease test. Under current guidelines, endoscopy is still recommended for the diagnosis of H. pylori infection in patients with alarm symptoms (e.g. GI bleeding, sudden weight loss, excessive vomiting, anemia), or patients over the age of 55. However, for younger patients not exhibiting alarm symptoms, non-invasive tests such as the urea breath test (UBT) or fecal antigen test are recommended for diagnosis of H. py/ori infection. Following completion of a treatment regimen of antibiotics and a proton pump inhibitor (PPI), it is recommended that patients be tested to verify eradication of H. pylori infection. Serum antibody tests are also available, but these are unable to distinguish between past and current infection. By detecting antigen present in fecal specimens, the H. PYLORI QUIK CHEK™ test allows for the non-invasive detection of H. pylori when endoscopy is not required.
Device Description
The H. PYLORI QUIK CHEK™ test utilizes antibodies specific for H. pylori antigen. The Membrane Device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies specific for H, pylori antigen. The ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any H. pylori antigen in the sample binds to the antibody-peroxidase conjugate. The antigen-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-H. pylori antigen antibodies in the test line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "C" and "T" sides of the Reaction Window. A blue line on the "T" side of the Reaction Window indicates a positive result. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay.
5
Materials Provided
- . Membrane Devices - 25 pouches, each pouch contains 1 device
- Conjugate (2.5 mL) Antibody specific for H. pylori antigen coupled to horseradish . peroxidase in a buffered protein solution
- Diluent (22 mL) Buffered protein solution with black graduated dropper assembly .
- Positive Control (2 mL) H. pylori antigen in a buffered protein solution .
- Substrate (3.5 mL) Solution containing tetramethylbenzidine ●
- Wash Buffer (12 mL) Buffered solution with white graduated dropper assembly ●
- Disposable plastic pipettes (50) Graduated at 25 µL, 100 µL, 200 µL, 300 µL, 400 µL and . 500 µL
- . Wooden applicator sticks (50)
The predicate device (ImmunoCard STAT!® HpSA) and the H. PYLORI QUIK CHEK™ test both detect H. pylori in fecal specimens and are substantially equivalent in principle. The following table shows a comparison of both devices.
| Predicate Device Comparison Table
| Similarities | ||
|---|---|---|
| Item | H. PYLORI QUIK CHEKTM | ImmunoCard STAT!® HpSA (K032222) |
| Intended Use | The TECHLAB® H. PYLORI QUIK CHEK™ | |
| test is a rapid membrane enzyme | ||
| immunoassay for the qualitative detection of | ||
| Helicobacter pylori specific antigen in a single | ||
| use cassette. It is intended for use with | ||
| human fecal specimens to aid in the diagnosis | ||
| of H. pylori infection and to demonstrate loss | ||
| of H. pylori antigen following treatment. The | ||
| test can be used with unpreserved fecal | ||
| specimens and fecal specimens preserved in | ||
| transport media from patients suspected of H. | ||
| pylori infection. Testing of patients to | ||
| demonstrate loss of H. pylori antigen following | ||
| treatment should be performed no sooner | ||
| than 4 weeks after completion of the | ||
| treatment regimen. Test results should be | ||
| taken into consideration by the physician in | ||
| conjunction with the patient history and | ||
| symptoms. | ImmunoCard STAT! HpSA is a rapid in | |
| vitro qualitative assay for the detection of | ||
| Helicobacter pylori antigen in human stool. | ||
| The stool antigen detection is intended to aid | ||
| in the diagnosis of H. pylori infection and to | ||
| demonstrate loss of H. pylori stool antigen | ||
| following treatment. Conventional medical | ||
| practice recommends that testing by any | ||
| method to confirm the loss of antigen be done | ||
| at least four weeks following completion of | ||
| therapy. | ||
| Measured | ||
| analyte | Detection of H. pylori stool antigen | Detection of H. pylori stool antigen |
| Target | ||
| Population | Persons suspected of having | |
| H. pylori infection | Same | |
| Type of Test | Qualitative | Same |
6
| Predicate Device Comparison Table
| Similarities (continued) | ||
|---|---|---|
| Item | H. PYLORI QUIK CHEK™ | ImmunoCard STAT!® HpSA (K032222) |
| Controls | Positive and negative control included in kit | |
| Internal Control line | Same | |
| Storage | Refrigerated (2°C – 8°C) | Same |
There are no differences between the subject device and the predicate(s) with respect to indications and intended use.
| Predicate Device Comparison Table
| Differences | ||
|---|---|---|
| ltem | H. PYLORI QUIK CHEKTM | ImmunoCard STAT!® HpSA (K032222) |
| Format | Single Use Membrane Cassette | |
| 25 tests | Single Use Lateral Flow Cassette | |
| 20 tests | ||
| Specimen Type | Fecal Specimens in Cary-Blair and C&S | |
| Transport Media | Unpreserved Fecal Specimen | |
| Time to Result | 30 minutes | 5 minutes |
| Technology | Enzyme Linked Immunoassay (ELISA) | Immunochromatographic (ICT) |
| Antibody Format | Polyclonal/Polyclonal | Monoclonal/Monoclonal |
Summary of Performance Data
The performance of the H. PYLORI QUIK CHEK™ test was evaluated at 6 independent sites. Patients were recruited that were undergoing endoscopy as part of routine care. A composite reference method (CRM) comparison was used in the evaluation consisting of rapid urease and histology of the biopsy samples. The following table shows a summary of the clinical performance data. The results of the study show that the H. PYLORI QUIK CHEK™ test exhibity of 97.0% and specificity 100% with CRM biopsy results.
7
Age and Gender Distribution
Age and gender information was available for 122 patients. The ages ranged from 19 to 82 years. Of the 122 patients tested, 68% were female and 32% were male. No difference in test performance was observed based on patient age or gender.
Initial Diagnosis H. PYLORI QUIK CHEK™ test versus Composite reference Method (CRM)
| N = 122 | CRM
Positive | CRM
Negative |
|----------------------------------|-----------------|-----------------|
| H. PYLORI QUIK CHEK™
Positive | 32 | 0 |
| H. PYLORI QUIK CHEK™
Negative | 1* | 89 |
| 95% Confidence Limits | ||
|---|---|---|
| Sensitivity | 97.0% | 84.7% - 99.5% |
| Specificity | 100.0% | 95.9% - 100.0% |
*Additional testing with an FDA cleared H. pylori stool antigen teste provided an antigen negative result.
Post-Therapy
For Eradication (post-therapy), there were 9 samples from patients being tested post therapy. The results show that the H. PYLORI QUIK CHEK™ test exhibited a sensitivity of 100% with the composite reference method.
| N = 9 | CRM
Positive | CRM
Negative | | | 95% Confidence Limits |
|----------------------------------|-----------------|-----------------|-------------|--------|-----------------------|
| H. PYLORI QUIK CHEK™
Positive | 9 | 0 | Sensitivity | 100.0% | 70.1% - 100.0% |
| H. PYLORI QUIK CHEK™
Negative | 0 | 0 | | | |
8
Retrospective Sample Study
A supplemental retrospective sample study was performed comparing the H. PYLORI QUIK CHEK™ test to an FDA cleared commercial ELISA. For this study, 200 samples (94 positive and 106 negative by the commercial ELISA). There was 98.9% Positive Agreement and 97.2% Negative Agreement of results between the assays.
| N = 200 | FDA Cleared Commercial
ELISA Positive | FDA Cleared Commercial
ELISA Negative |
|----------------------------------|------------------------------------------|------------------------------------------|
| H. PYLORI QUIK CHEK™
Positive | 93 | 3* |
| H. PYLORI QUIK CHEK™
Negative | 1** | 103 |
| 95% Confidence Limits | ||
|---|---|---|
| Percent Positive Agreement | 98.9% | 94.2% - 99.8% |
| Percent Negative Agreement | 97.2% | 92.0% - 99.0% |
*H. pylori DNA was amplified from the samples with PCR
**No H. pylori DNA was amplified from the sample with PCR
Reproducibility
The reproducibility of the H. PYLORI QUIK CHEK™ test was determined using 8 fecal specimens that were coded to prevent identification during testing. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The samples were tested in triplicate twice a day over a 5day period by multiple technicians at each site using 2 different kit lots. The results were as expected among the different locations, and exhibited an overall percent agreement of 100%.
Analytical Sensitivity
The Limit of Detection (LoD) for the H. PYLORI QUIK CHEK™ test was established at 16.08 ng/ml. in fecal matrix (0.24 ng/test) for Helicobacter pylori antigen using cell lysate antigen prepared from H. pylori strain ATCC 43526. For specimens in Protocol™ Cary Blair media, the LoD was established at 13.01 ng/mL (0.20 ng/test). For specimens in Protocol™ C&S media, the LoD was established at 19.96 ng/mL (0.31 ng/test).
Analytical Specificity (Cross Reactivity)
The H. PYLORI QUIK CHEK™ test was evaluated for cross-reactivity with common intestinal organisms and viruses listed below. None of the organisms or viruses were shown to interfere with the performance of the H. PYLORI QUIK CHEK™ test.
Acinetobacter baumannii Borrelia burgdorferi Campylobacter helveticus Campylobacter lari Clostridium bifermentans Edwardsiella tarda
Bacillus cereus Campylobacter coli Campylobacter hyointestinalis Campylobacter upsaliensis Clostridium difficile Enterobacter cloacae
Bacillus subtilis Campylobacter fetus Campylobacter jejuni Candida albicans Clostridium perfringens Enterococcus faecalis
9
Escherichia coli Escherichia coli ETEC Escherichia coli 0157:H7 (toxigenic) Listeria monocytogenes Prevotella melaninogenica Pseudomonas fluorescens Staphylococcus aureus (Cowan's)
Adenovirus Types 2. 40 Echovirus 9, 22
Escherichia coli EIEC Escherichia coli 0157:H7 (non-toxigenic) Haemophilus influenzae Peptostreptococcus anaerobius Proteus vulgaris Salmonella typhimurium Streptococcus aqalactiae
Human Coronavirus Enterovirus 70
Escherichia coli EPEC Lactobacillus acidophilus Porphyromonas asaccharolytica Pseudomonas aeruginosa Staphylococcus aureus Yersinia enterocolitica
Coxsackievirus B1. B2. B3. B6 Human Rotavirus
Inclusivity Study
The following strains, which include isolates representing described H. pylori populations, were tested for reactivity with the H. PYLORI QUIK CHEK™ test. All strains tested generated a positive result.
| ATCC 700392 | ATCC 43526 | ATCC 700824 |
|---|---|---|
| JP26 | ATCC 43504 | ATCC 43579 |
Interfering Substances (U.S. Formulation)
The following substances had no effect on positive H. PYLORI QUIK CHEK™ test results analyzed at the concentrations indicated:
Barium sulfate (5% w/v), Benzalkonium Chloride (1% w/v), Ciprofloxacin (0.25% w/v), Ethanol (1% w/v), Hog gastric mucin (3.5% w/v), Human blood (40% v/v), Hydrocortisone (1% w/v), Imodium® (5% v/v), Kaopectate® (5% v/v), Leukocytes (0.05% v/v), Maalox® Advanced (5% v/v), Mesalazine (10% w/v), Metronidazole (0.25% w/v), MiraLax® (3350 PEG)(7% w/v), Mineral Oil (10% w/v), Mylanta® (4.2 mq/mL), Naproxen Sodium (5% w/v), Nonoxynol-9 (1% w/v), Palmitic Acid/Fecal Fat (40% w/v), Pepto-Bismo® (5% v/v), Phenvlephrine (1% w/v), Prilosec OTC® (5 µg/mL), Sennosides (1% w/v), Simethicone (10% w/v), Stearic Acid/Fecal Fat (40% w/v), Tagamet® (5 ug/mL), TUMS® (50 µg/mL), Human Urine (5% v/v), and Vancomycin (0.25% w/v).
Prozone
To ensure that a high concentration of H. pylori antigen does not interfere with a positive reaction in the H. PYLORI QUIK CHEK™ test, high positive samples were prepared by spiking a negative fecal pool at concentrations up to 10 times the highest concentration of antigen observed in a positive clinical specimen. A total of 5 different dilutions of H. pylori antigen was prepared and tested in triplicate. The results demonstrated that there was no overall prozone effect, that elevated levels of antigen did not affect the detection of the antigen.
CONCLUSION
The conclusions drawn from the nonclinical and clinical tests demonstrate that the H. PYLORI QUIK CHEK™ test is safe and effective and substantially equivalent to the predicate device in performance. The information submitted in this premarket notification is complete and supports a substantial equivalence decision.