(84 days)
Not Found
No
The device description and performance studies focus on a traditional enzyme immunoassay method for detecting antigens, with no mention of AI/ML techniques for analysis or interpretation.
No
This device is an in vitro diagnostic test for the detection of Helicobacter pylori antigen; it aids in diagnosis but does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection."
No
The device description clearly outlines a physical enzyme immunoassay kit with components like a Microassay Plate, Conjugate, and Substrate, indicating it is a hardware-based diagnostic test, not software only.
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" 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 test samples taken from the human body to provide information about a person's health status.
- Device Description: The description details an "enzyme immunoassay" that uses antibodies to detect an antigen in a biological sample (fecal specimen). This is a common method for in vitro diagnostic tests.
- Anatomical Site: The test is performed on "human fecal specimens," which are samples taken from the human body.
- Performance Studies: The document describes clinical performance studies evaluating the test's sensitivity and specificity against a "composite reference method" using patient samples. This is typical for the validation of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K053335; Premier® Platinum HpSA® PLUS) is a strong indicator that this device is being compared to an already cleared IVD, which is a standard process for regulatory submission of new IVDs.
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 CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. 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 consician 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 CHEK™ test uses antibodies specific to H. pylori antigen. The Microassay Plate in the kit contains immobilized capture antibodies aqainst H. pylori antigen. The Conjugate consists of antibodies specific to H, pylori antigen conjucated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Coniugate and to the immobilized capture antibody during the incubation phase. Any unbound material is removed during the washing steps. Following the addition of Substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of antigen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The ages ranged from 19 to 82 years.
Intended User / Care Setting
Not Found
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 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.
For the retrospective sample study, 196 samples (75 positive and 121 negative by the commercial ELISA) were evaluated, with the FDA cleared commercial ELISA used as the reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data (Initial Diagnosis):
Study type: Composite Reference Method (CRM) comparison
Sample size: N = 109 patients
Key results: Sensitivity of 100% and specificity of 96.1% with CRM biopsy results.
Visual results were the same as dual wavelength spectrophotometric results 99% of the time.
Post-Therapy Eradication Study:
Sample size: N = 9
Key results: Sensitivity of 77.8% with the composite reference method.
Retrospective Sample Study:
Study type: Comparison to an FDA cleared commercial ELISA
Sample size: N = 196 samples (75 positive and 121 negative by the commercial ELISA)
Key results: There was 100% correlation of results between the assays.
Reproducibility Study:
Study type: Inter-laboratory and intra-laboratory study
Sample size: 8 fecal specimens
Key results: Results were consistent among the different locations and exhibited a correlation of 97.5%.
Analytical Specificity (Cross Reactivity):
Study type: Evaluation of cross-reactivity with common intestinal organisms and viruses.
Key results: None of the organisms or viruses were shown to interfere with the performance of the H. PYLORI CHEK™ test.
Inclusivity Study:
Study type: Testing of H. pylori strains.
Key results: All strains tested generated a positive result.
Interfering Substances Study:
Study type: Evaluation of various substances on test results.
Key results: The listed substances had no effect on positive or negative H. PYLORI CHEK™ test results analyzed at the concentrations indicated.
Analytical Sensitivity (Limit of Detection - LoD):
LoD for H. pylori antigen in fecal matrix: 6.70 ng/mL (0.13 ng/test).
LoD for specimens in Cary Blair media: 26.57 ng/mL (0.33 ng/test).
LoD for specimens in C&S media: 18.19 ng/mL (0.23 ng/test).
Precision - Intra-Assay:
Study type: Analysis of fecal samples.
Sample size: 8 fecal samples (2 negative, 2 high negative, 2 low positive, 2 moderate positive).
Key results: Positive specimens tested as expected and negative specimens consistently tested negative.
Precision - Inter-Assay:
Study type: Analysis of fecal samples over time by multiple technicians.
Sample size: 8 fecal samples (2 negative, 2 high negative, 2 low positive, 2 moderate positive).
Key results: Positive samples tested as expected 98.3% of the time and the negatives tested as expected 97.8% of the time.
Fresh Versus Frozen Samples Study:
Study type: Evaluation of the effect of long term frozen specimen storage on antigen stability.
Sample size: 32 fecal specimens (2 negative, 5 high negative, 10 low positive, 15 positive).
Key results: No conversion of positive-to-negative or negative was observed in any of the samples at the specified time points (stored
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2018
TECHLAB. Inc. Donna Link Director Regulatory and Compliance 2001 Kraft Drive Corporate Research Center Blacksburg, Virginia 24060
Re: K181400
Trade/Device Name: H. Pylori Chek Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR Dated: May 24, 2018 Received: May 29, 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 post marketing 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) K181400
Device Name H. PYLORI CHEK
Indications for Use (Describe)
The TECHLAB H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. 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 consician in conjunction with the patient history and symptoms.
| Type of Use (Select one or both, as applicable) | Research Use (Part 21 CFR 801.4, Subpart B) Testing Sample Use (21 CFR 809.3(c)) | Research Use (Part 21 CFR 801.4, Subpart B) | Testing Sample Use (21 CFR 809.3(c)) |
|---|---|---|---|
| Research Use (Part 21 CFR 801.4, Subpart B) | |||
| Testing Sample Use (21 CFR 809.3(c)) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
H. PYLORI 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 20, 2018 |
|---|---|
| Name: | TECHLAB, Inc. |
| Address: | 2001 Kraft Drive |
| Corporate Research Center | |
| Blacksburg, VA 24060 USA | |
| Contact Person: | Donna T. Link |
| 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 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
CC Microbiology
1.7 Reason for Premarket Notification
The development of a new enzyme immunoassay for the qualitative detection of H. pylori specific antigen.
4
Intended Use
The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pv/or/infection and to demonstrate loss of H. pv/ori 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.
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 biopsied tissue is tested for the presence of H. pylori by culture, histology, or rapid urease test. Under current quidelines, endoscopy is still recommended for the diagnosis of H. pylori infection in patients with alarm symptoms (e.g. Gl 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. pylori 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 distinquish between past and current infection. By detecting antigen present in fecal specimens, the H. PYLORI CHEK™ test allows for the non-invasive detection of H. pylori when endoscopy is not required.
Device Description
The H. PYLORI CHEK™ test uses antibodies specific to H. pylori antigen. The Microassay Plate in the kit contains immobilized capture antibodies aqainst H. pylori antigen. The Conjugate consists of antibodies specific to H, pylori antigen conjucated to horseradish peroxidase. In the assay, an aliquot of a diluted fecal specimen is transferred to a microassay well containing the Conjugate. If the antigen is present in the specimen, it will bind to the Coniugate and to the immobilized capture antibody during the incubation phase. Any unbound material is removed during the washing steps. Following the addition of Substrate, a color is detected due to the enzyme-antibody-antigen complexes that formed in the presence of antigen.
Materials Provided
- . Microassay Plate – 12 strips, each consisting of 8 wells coated with antibodies to H. pylori antigen (stored with desiccant)
- Conjugate (7 mL) Antibodies to H. pylori antigen coupled to horseradish peroxidase in a . buffered protein solution containing 0.05% ProClin® 300
- Diluent (40 mL) Buffered protein solution containing 0.05% ProClin® 300. The Diluent is also ● to be used as the neqative control solution.
- Positive Control (3.5 mL) H. pylori antigen in a buffered protein solution containing 0.05% ● ProClin® 300
- . Stop Solution (7 mL) – 0.6 N sulfuric acid. CAUTION: Avoid contact with skin or eyes; flush with water immediately if contact occurs
- Substrate (14 mL) solution containing tetramethylbenzidine and peroxide .
5
- Wash Buffer Concentrate (50 mL) 20X concentrate containing phosphate buffered saline, . detergent, and 0.2% thimerosal
Accessories: 100 Disposable plastic transfer pipettes 2 Plastic adhesive sheets 1 Wash Solution Label 50 Wooden Applicator sticks
The predicate device (Premier® PLATINUM HPSA PLUS) and the H. PYLORI CHEK™ test use the same ELISA (enzyme linked immunosorbent assay) technology and are substantially equivalent in principle. The following tables show a comparison of both devices' similarities and differences.
| Item | H. PYLORI CHEKTM | Premier® Platinum HpSA® PLUS
(K053335) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TECHLAB H. PYLORI CHEKTM test
is an enzyme immunoassay for the
qualitative detection of Helicobacter pylori
specific antigen. 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. | Premier® Platinum HpSA PLUS enzyme
immunoassay (EIA) is an in vitro qualitative
procedure for the detection of Helicobacter
pylori antigens in human stool. Test results
are intended to aid in the diagnosis of H.
pylori infection and to monitor response
during and post-therapy in patients.
Accepted medical practice recommends
that testing by any current method, to
confirm eradication, be done at least four
weeks following completion of therapy. |
| Measured analyte | Detection of H. pylori antigen | Same |
| Type of Test | Qualitative | Same |
| Controls | Positive and negative control included in
the kit | Same |
| Target Population | Persons suspected of having
H. pylori infection | Same |
| Storage | Refrigerated (2°C – 8°C) | Same |
| Reading Method | Visual, Spectrophotometric | Same |
| Predicate Device Comparison Table
Differences | | |
| Item | H. PYLORI CHEK TM | Premier® Platinum HpSA® PLUS
(K053335) |
| Specimen Type | Fresh or frozen formed, semi-solid, and liquid fecal specimens. Fecal specimens in Cary-Blair and C&S Transport Media | Fresh or frozen formed, semi-solid, and liquid fecal specimens |
| Specimen Storage | Specimens may be held up to 96 hours at 2°C – 8°C or at 20°C – 25°C prior to testing | Specimens may be held up to 72 hours at 2°C – 8°C prior to testing |
| Incubation Temp | 37°C ± 2°C | 19°C – 27°C |
| Time to Result | Approximately 1 hour | Approximately 1 hour |
| Antibody Format | Polyclonal/Polyclonal | Monoclonal/Monoclonal |
There are no differences between the subject device and the predicate(s) with respect to indications and intended use.
6
7
Summary of Performance Data
The performance of the H. PYLORI 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 CHEK™ test by dual wavelength spectrophotometric analysis, exhibited sensitivity of 100% and specificity of 96.1% with CRM biopsy results. Testing was also conducted by visual reading of plates. Visual results were the same as dual wavelength spectrophotometric results 99% of the time.
Age and Gender Distribution
Age information was available (from the prospective study Initial Diagnosis group) for 109 patients. The ages ranged from 19 to 82 years. The gender identification was available for 109 patients. Of the 109 patients tested, 66% were female and 34% were male. No difference in test performance was observed based on patient age or gender.
Initial Diagnosis H. PYLORI CHEK™ test versus Composite reference Method (CRM)
| N = 109 | CRM
Positive | CRM
Negative |
|-------------------------------------|-----------------|-----------------|
| H. PYLORI CHEKTM
Positive | 32 | 3* |
| H. PYLORI CHEKTM
Negative | 0 | 74 |
| 95% Confidence Limits | ||
|---|---|---|
| Sensitivity | 100% | 89.3% - 98.9% |
| Specificity | 96.1% | 89.2% - 98.7% |
*All three specimens tested positive initially by the H. PYLORI CHEK™ test, but negative upon re-testing with the H. PYLORI CHEK™ test.
Post-Therapy
For Eradication (post-therapy), there were 9 samples from patients being tested post therapy. The results show that the H. PYLORI CHEK™ test exhibited a sensitivity of 77.8% with the composite reference method.
| N = 9 | CRM
Positive | CRM
Negative |
|-----------------------------|-----------------|-----------------|
| H. PYLORI CHEK™
Positive | 7* | 0 |
| H. PYLORI CHEK™
Negative | 2** | 0 |
| 95% Confidence Limits | ||
|---|---|---|
| Sensitivity | 77.8% | 45.3% - 93.7% |
- One specimen tested positive by visual read but negative by spectrophotometric interpretation (OD450/620 0.034).
**One specimen tested negative initially but positive upon re-testing with the H. PYLORI CHEK™ test.
8
Retrospective Sample Study
A supplemental retrospective sample study was performed comparing the H. PYLORI CHEK™ test to an FDA cleared commercial ELISA. For this study, 196 samples (75 positive and 121 negative by the commercial ELISA) were evaluated. There was 100% correlation of results between the assays.
| N = 196 | FDA Cleared
Commercial ELISA
Positive | FDA Cleared Commercial
ELISA Negative |
|--------------------------------------|---------------------------------------------|------------------------------------------|
| H. PYLORI CHEK TM
Positive | 75 | 0 |
| H. PYLORI CHEK TM
Negative | 0 | 121 |
| 95% Confidence Limits | ||
|---|---|---|
| Percent Positive Agreement | 100.0% | 95.1% - 100.0% |
| Percent Negative Agreement | 100.0% | 96.9% - 100.0% |
Reproducibility
The reproducibility of the H. PYLORI 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 5-day period by multiple technicians at each site using 2 different kit lots. The results were consistent among the different locations and exhibited a correlation of 97.5%.
Analytical Specificity (Cross Reactivity)
The H. PYLORI 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 CHEK™ test.
| Acinetobacter baumannii | Bacillus cereus | Bacillus subtilis |
|---|---|---|
| Borrelia burgdorferi | Campylobacter coli | Campylobacter fetus |
| Campylobacter helveticus | Campylobacter hyointestinalis | Campylobacter jejuni |
| Campylobacter lari | Campylobacter upsaliensis | Candida albicans |
| Clostridium bifermentans | Clostridium difficile | Clostridium perfringens |
| Edwardsiella tarda | Enterobacter cloacae | Enterococcus faecalis |
| Escherichia coli | Escherichia coli EIEC | Escherichia coli EPEC |
| Escherichia coli ETEC | Escherichia coli O157:H7 (non-toxigenic) | Lactobacillus acidophilus |
| Escherichia coli O157:H7 (toxigenic) | Haemophilus influenzae | Porphyromonas asaccharolytica |
| Listeria monocytogenes | Peptostreptococcus anaerobius | Pseudomonas aeruginosa |
| Prevotella melaninogenica | Proteus vulgaris | Staphylococcus aureus |
| Pseudomonas fluorescens | Salmonella typhimurium | Yersinia enterocolitica |
| Staphylococcus aureus (Cowan's) | Streptococcus agalactiae | |
| Adenovirus Types 2, 40 | ||
| Echovirus 9, 22 | Human Coronavirus | |
| Enterovirus 70 | Coxsackievirus B1, B2, B3, B6 | |
| Human Rotavirus |
9
700824 43579
Inclusivity Study
The following strains, which include isolates representing described H. pylori populations, were tested for reactivity with the H. PYLORI CHEK™ test. All strains tested generated a positive result.
| ATCC 700392 | ATCC 43526 | ATCC |
|---|---|---|
| JP26 | ATCC 43504 | ATCC |
Interfering Substances (U.S. Formulation)
The following substances had no effect on positive or negative H. PYLORI 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 mg/mL), Naproxen Sodium (5% w/v), Nonoxynol-9 (1% w/v), Nystatin (1% w/v), Palmitic Acid/Fecal Fat (40% w/v), Pepto-Bismol® (5% v/v), Phenylephrine (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).
Analvtical Sensitivity
The Limit of Detection (LoD) for the H. PYLORI CHEK™ test was established at 6.70 ng/mL in fecal matrix (0.13 ng/test) for Helicobacter pylori antigen using cell lysate antigen prepared from H. pylori strain ATCC 43526. For specimens in Cary Blair media, the LoD was established at 26.57 ng/mL (0.33 ng/test). For specimens in C&S media, the LoD was established at 18.19 ng/mL (0.23 ng/test).
Precision - Intra-Assay
For the determination of intra-assay performance, 8 fecal samples were analyzed by the H. PYLORI CHEK™ test. The samples included 2 negative. 2 high negative. 2 low positive, and 2 moderate positive samples. Each specimen was assayed a total of five times using two different kit lots. Positive specimens tested as expected and negative specimens consistently tested negative.
Precision - Inter-Assay
For the determination of inter-assay performance, 8 fecal samples were analyzed by the H. PYLORI CHEK™ test. The samples included 2 negative, 2 high negative, 2 low positive, and 2 moderate positive samples. The samples were tested twice a day by multiple technicians over a 12-day period using 2 different kit lots. The positive samples tested as expected 98.3% of the time and the negatives tested as expected 97.8% of the time.
Fresh Versus Frozen Samples
The effect of long term frozen specimen storage on antigen stability was evaluated. For the analysis, a total of 32 fecal specimens was tested with the H. PYLORI CHEK™ test. The fecal specimens consisted of 2 negative fecal samples, 5 high negative fecal samples, 10 low positive fecal samples, and 15 positive fecal samples covering the range of the test (50 ng/mL - 1200 ng/mL). Samples were prepared and stored ≤ -10°C and ≤ -70°C and tested at 0, 5, 10, and 14 days. No conversion of positive-to-negative or negative was observed in any of the samples at the specified time points.
10
Prozone
To ensure that a high concentration of H. pylori antigen does not interfere with a positive reaction in the H. PYLORI 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 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.