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.

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.

AI/ML Overview

Acceptance Criteria and Study for H. PYLORI CHEK™ Test

This document describes the acceptance criteria for the H. PYLORI CHEK™ test, an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in human fecal specimens, and the studies performed to demonstrate that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implicit from Predicate/Clinical Need)	Reported Device Performance (H. PYLORI CHEK™)
Initial Diagnosis
Sensitivity	High sensitivity to detect H. pylori infections.	100% (95% CI: 89.3% - 98.9%) against Composite Reference Method (CRM)
Specificity	High specificity to avoid false positives.	96.1% (95% CI: 89.2% - 98.7%) against CRM
Post-Therapy
Sensitivity	Acceptable sensitivity to demonstrate loss of antigen	77.8% (95% CI: 45.3% - 93.7%) against CRM
Retrospective Sample Study
Percent Positive Agreement	100% agreement with FDA cleared commercial ELISA	100% (95% CI: 95.1% - 100.0%)
Percent Negative Agreement	100% agreement with FDA cleared commercial ELISA	100% (95% CI: 96.9% - 100.0%)
Reproducibility	Consistent results across sites, operators, and lots.	97.5% correlation among different locations, multiple technicians, and two kit lots over a 5-day period.
Analytical Specificity (Cross-Reactivity)	No interference from common intestinal organisms and viruses.	None of the tested common intestinal organisms or viruses interfered with device performance.
Inclusivity	Reactivity with described H. pylori populations.	All tested H. pylori strains (including ATCC 700392, ATCC 43526, ATCC 43504, JP26) generated a positive result.
Interfering Substances	No effect on results from specified interfering substances.	No effect on positive or negative results from a comprehensive list of substances (e.g., medications, food components).
Analytical Sensitivity (LoD)	Low limit of detection for H. pylori antigen.	6.70 ng/mL in fecal matrix (0.13 ng/test); 26.57 ng/mL in Cary-Blair media; 18.19 ng/mL in C&S media.
Precision (Intra-Assay & Inter-Assay)	Consistent results within and between assays.	Positive specimens tested as expected; negative specimens consistently tested negative (intra-assay). Positive samples tested as expected 98.3%, negatives 97.8% (inter-assay).
Fresh vs. Frozen Samples	Antigen stability maintained in frozen samples.	No conversion of positive-to-negative or negative-to-positive results in samples stored frozen for up to 14 days.
Prozone Effect	No high-dose hook effect.	No overall prozone effect observed; elevated antigen levels did not affect detection.

2. Sample Size and Data Provenance for Test Sets

Initial Diagnosis: 109 patients. The data was collected prospectively from patients undergoing endoscopy as part of routine care at 6 independent sites. The country of origin is not explicitly stated but is implicitly within the US given the FDA submission.
Post-Therapy: 9 samples from patients being tested post-therapy. Data provenance is similar to the initial diagnosis group (prospectively collected, unclear country of origin but likely US).
Retrospective Sample Study: 196 samples (75 positive, 121 negative by comparison ELISA). The provenance is "retrospective," and the country of origin is not specified but commonly implies US labs for FDA submissions unless otherwise noted.

3. Number of Experts and Qualifications for Ground Truth in Test Set

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience as a radiologist) for establishing the ground truth.

For the Initial Diagnosis and Post-Therapy studies, the ground truth was established by a Composite Reference Method (CRM). This CRM consisted of:
* Rapid urease testing of biopsy samples.
* Histology of biopsy samples.

For the Retrospective Sample Study, the ground truth was an FDA cleared commercial ELISA.

4. Adjudication Method for the Test Set

The adjudication method for establishing the ground truth based on the Composite Reference Method (CRM) (rapid urease and histology) is not explicitly described. It is implied that a consensus or predefined rule was used to combine these two methods to determine the CRM positive or negative status. No adjudication by human readers for the device under evaluation is mentioned for this standalone performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. This study focuses on the standalone performance of the diagnostic test.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The performance data for the H. PYLORI CHEK™ test (e.g., sensitivity, specificity, agreement) are reported as the performance of the device without human interpretation (other than reading the device output). While visual reading of plates was also mentioned (achieving 99% agreement with spectrophotometric results), the primary reported performance metrics are based on the more objective dual wavelength spectrophotometric analysis.

7. Type of Ground Truth Used

The type of ground truth used was:

Composite Reference Method (CRM): For the initial diagnosis and post-therapy studies, which combined rapid urease and histology from biopsy samples. This is considered a high-standard clinical ground truth.
FDA cleared commercial ELISA: For the retrospective sample study, representing a comparative method ground truth.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. This type of device (enzyme immunoassay) typically does not involve a "training set" in the same way machine learning algorithms do. Instead, it relies on extensive analytical validation and clinical performance studies to establish its effectiveness.

9. How Ground Truth for the Training Set Was Established

As no explicit training set for an AI/ML algorithm is mentioned, there is no information provided on how ground truth for a training set would have been established. The development of this immunoassay would involve internal R&D and validation, but these stages are distinct from the "training set" concept in AI/ML.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181400

Device Name H. PYLORI CHEK

Indications for Use (Describe)

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)

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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 DriveCorporate Research CenterBlacksburg, 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.

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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

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 .

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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 testis an enzyme immunoassay for thequalitative detection of Helicobacter pylorispecific antigen. It is intended for usewith human fecal specimens to aid in thediagnosis of H. pylori infection and todemonstrate loss of H. pylori antigenfollowing treatment. The test can be usedwith unpreserved fecal specimens andfecal specimens preserved in transportmedia from patients suspected of H.pylori infection. Testing of patients todemonstrate loss of H. pylori antigenfollowing treatment should be performedno sooner than 4 weeks after completionof the treatment regimen. Test resultsshould be taken into consideration by thephysician in conjunction with the patienthistory and symptoms.	Premier® Platinum HpSA PLUS enzymeimmunoassay (EIA) is an in vitro qualitativeprocedure for the detection of Helicobacterpylori antigens in human stool. Test resultsare intended to aid in the diagnosis of H.pylori infection and to monitor responseduring and post-therapy in patients.Accepted medical practice recommendsthat testing by any current method, toconfirm eradication, be done at least fourweeks following completion of therapy.
Measured analyte	Detection of H. pylori antigen	Same
Type of Test	Qualitative	Same
Controls	Positive and negative control included inthe kit	Same
Target Population	Persons suspected of havingH. pylori infection	Same
Storage	Refrigerated (2°C – 8°C)	Same
Reading Method	Visual, Spectrophotometric	Same
Predicate Device Comparison TableDifferences
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.

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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	CRMPositive	CRMNegative
H. PYLORI CHEKTMPositive	32	3*
H. PYLORI CHEKTMNegative	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	CRMPositive	CRMNegative
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.

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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 ClearedCommercial ELISAPositive	FDA Cleared CommercialELISA Negative
H. PYLORI CHEK TMPositive	75	0
H. PYLORI CHEK TMNegative	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, 40Echovirus 9, 22	Human CoronavirusEnterovirus 70	Coxsackievirus B1, B2, B3, B6Human Rotavirus

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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.

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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.

Regulation Number and Section

§ 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).