The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

Device Description

The CAMPYLOBACTER CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacter-specific antigen conjugated 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 Conjugate 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

The document describes the CAMPYLOBACTER CHEK™ test, an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. It is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it presents the reported performance from a prospective clinical study, which implicitly serves as the successful demonstration of performance for clearance. The predicate device's performance is not provided in a comparative table within the document, so a direct comparison of acceptance criteria to predicate performance isn't possible from the given text.

Performance Metric	Reported Device Performance (CAMPYLOBACTER CHEK™ test)
Sensitivity	91.4%
Specificity	99.1%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Prospective Study): N = 1552 patients.
Data Provenance: The prospective study was conducted at "4 independent sites." The country of origin is not explicitly stated, but the document refers to the "U.S. Formulation" for interfering substances testing, suggesting a U.S. context for the clinical studies. The data is prospective, meaning specimens were collected and tested over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the prospective study was primarily established by bacterial culture.

Number of Experts: Not specified.
Qualifications: Since traditional bacterial culture is the method, it would implicitly involve trained laboratory technologists or microbiologists. Specific qualifications (e.g., radiologist with X years of experience) are not applicable or provided in this context as it's not an imaging device.

4. Adjudication Method for the Test Set

The primary comparison was between the CAMPYLOBACTER CHEK™ test and culture. For discrepant specimens (14 culture-negative/device-positive and 3 culture-positive/device-negative), additional testing was performed at TECHLAB.

Adjudication Method: "The 17 discrepant specimens were further characterized by additional testing at TECHLAB. This testing included an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing." This indicates a multi-method adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that produces a qualitative result, not an imaging device requiring human reader interpretation in the context of improving diagnostic accuracy with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance reported (Sensitivity 91.4%, Specificity 99.1%) is for the CAMPYLOBACTER CHEK™ test operating as a standalone diagnostic assay. The results are read by either visual inspection or spectrophotometric means, but the performance metrics reflect the direct output of the assay compared to the reference method (culture).

7. The Type of Ground Truth Used

Primary Ground Truth: Bacterial Culture (for the prospective study).
Adjudication Ground Truth: For discrepant results, a combination of "FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing." This represents a form of expert consensus or multi-method confirmation based on established diagnostic techniques.

8. The Sample Size for the Training Set

The document describes performance studies, but it does not mention a training set in the context of an algorithm or machine learning model. This device is an enzyme immunoassay (EIA) kit, which is a laboratory test, not an AI/ML software device. Therefore, the concept of a "training set" for an algorithm is not applicable here. The development of the assay itself would have involved extensive R&D and optimization, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" for an algorithm is not applicable to this device. Therefore, no ground truth for a training set was established in the context of AI/ML development.

Summary

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January 22, 2018

Techlab, Inc. Donna Link Director Regulatory and Compliance 2001 Kraft Drive Blacksburg, Virginia 24060-6358

Re: K173219

Trade/Device Name: CAMPYLOBACTER CHEK Regulation Number: 21 CFR 866.3110 Regulation Name: Campvlobacter fetus serological reagents Regulatory Class: Class I Product Code: LQP Dated: September 29, 2017 Received: October 25, 2017

Dear Ms. 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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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) K173219

Device Name CAMPYLOBACTER CHEK

Indications for Use (Describe)

The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacterspecific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

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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CAMPYLOBACTER 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:	January 22, 2018
Name:	TECHLAB, Inc.
Address:	2001 Kraft DriveCorporate Research CenterBlacksburg, 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

CAMPYLOBACTER CHEK™

1.3 Common Name or Classification Name

Campylobacter spp. detection test

1.4 Classification and Regulation Class I 21 CFR 866.3110; Campylobacter fetus serological reagents
1.5 Product Code LQP - Campylobacter spp.
1.6 Panel Microbiology

Reason for Premarket Notification 1.7

The development of a new qualitative microwell ELISA test for the detection of Campylobacter spp.

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Intended Use

Explanation

Worldwide, Campylobacter species are the most common cause of bacterial gastroenteritis, with 400-500 million cases of diarrhea each year. Infants in developing countries are at even greater risk, as are travelers to those countries. Campylobacter-associated gastroenteritis is estimated to affect nearly 1 million people a year in the USA. In approximately 1 of 1000 cases, Campylobacter jejuni is closely linked to the subsequent development of Guillian-Barre Syndrome, an acute auto-immune paralysis. C. iejuni infection has also been associated with reactive arthritis in both children and adults. When individuals with severe symptoms of gastroenteritis seek medical help, the clinician is faced with multiple possible causes that can present with similar clinical features (e.q., diarrhea. nausea, vomiting, fever, abdominal pain) but that require very different, often conflicting, types of treatment.

For Campylobacter, the current standard for identification is bacterial culture followed by microscopic examination of the organisms. Although this traditional method is straightforward, it has two major limitations. First, pathogenic species of Campylobacter are microaerophilic or strictly anaerobic, so that exposure of culture or feces to environmental oxygen leads to death or inactivation of the bacteria. Thus, during transport or storage of specimens under aerobic conditions, the number of viable organisms can decrease, leading to potentially inaccurate culture results. Second, Campylobacter species are slowgrowing, requiring from 48-72 hr before reaching a point where the culture can safely be reported as negative. Such delavs can leave the clinician in a quandary and the patient with non-specific, ineffective. or even inappropriate treatment.

The CAMPYLOBACTER CHEK™ test allows detection of Campylobacter jejuni and Campylobacter coli, the species most commonly associated with human disease, in less than 60 minutes. Furthermore, the CAMPYLOBACTER CHEK™ test does not rely on bacterial viability, and can be performed on the bench-top with samples that have been exposed to air.

Device Description

The CAMPYLOBACTER CHEK™ test uses antibodies that recognize a Campylobacter-specific antigen. The Microassay Plate in the kit contains immobilized capture monoclonal antibodies against a Campylobacter-specific antigen. The Conjugate consists of polyclonal antibodies to a Campylobacterspecific antigen conjugated 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 Conjugate 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 monoclonal antibodies to a Campylobacter-specific antigen (stored with desiccant)

Conjugate (7 mL) – Antibodies to a Campylobacter-specific 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 negative control solution.

Positive Control (3.5 mL) - Campylobacter-specific antigen in a buffered protein solution containing 0.05% ProClin® 300

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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

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

Predicate Device Information

The predicate device (Premier® CAMPY) and the CAMPYLOBACTER 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.

Similarities
Item	DeviceK173219	PredicateK083464
Indications for use	The CAMPYLOBACTER CHEKtest is an enzyme immunoassay for thequalitative detection of aCampylobacter-specific antigen inhuman fecal specimens. TheCAMPYLOBACTER CHEK test isdesigned to detect C. jejuni and C. colifrom patients with symptoms ofgastroenteritis.The test is intended foruse with preserved fecal specimens intransport media and unpreservedhuman fecal specimens. Test resultsshould be considered in conjunctionwith clinical findings and patienthistory.	Premier CAMPY enzymeimmunoassay (EIA) is an invitro qualitative procedure forthe detection of specificCampylobacter antigens instool samples from patientswith signs and symptoms ofgastroenteritis. PremierCAMPY detects C. jejuni andC. coli in human stool thatmay be either unpreserved orpreserved in Cary Blair-basedtransport media. Test resultsare to be used in conjunctionwith information obtainedfrom the patient's clinicalevaluation and otherdiagnostic procedures.Premier CAMPY isintended for use in hospital,reference or state laboratorysettings. The device is notintended for point-of-careuse.
Measured analyte	Detection of Campylobacter-specific antigens (C. jejuni and C. coli)	Same
Specimen Type	Fecal specimens in Cary-Blair andC&S Transport Media	Same

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Similarities
Item	DeviceK173219	PredicateK083464
Type of Test	Qualitative	Same
Controls	Positive and negative controlincluded in the kit	Same
TargetPopulation	Persons suspected of havingCampylobacter infection	Same
Storage (kit)	Refrigerated (2°C – 8°C)	Same
Reading Method	Visual, Spectrophotometric	Same

Differences
Item	DeviceK173219	PredicateK083464
Time to Result	~1 hour	~2 hours
Antibody Format	Monoclonal/Polyclonal	Monoclonal/Monoclonal
Endpointdeterminations (dualwavelength)	≥ 0.120	≥ 0.100
Endpointdeterminations (singlewavelength)	≥ 0.080	≥ 0.150

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

Prospective Study

The performance of the CAMPYLOBACTER CHEK™ test was evaluated at 4 independent sites. Prospective incoming fecal specimens were collected and tested by culture and the CAMPYLOBACTER CHEK™ test. The following table shows a summary of the clinical performance of the CAMPYLOBACTER CHEK™ test for all 4 sites combined. The results of the study show that the CAMPYLOBACTER CHEK™ test exhibited a sensitivity of 91.4%, and a specificity of 99.1% with culture.

Age and Gender Distribution

Age information was available for 1552 patients. The ages ranged from less than 1 year to 100 years. Of the 1552 patients, 15.7% were ≤ 18 years. The gender identification was 38.7% females and 61.3% males. No difference in test performance was observed based on patient age or gender.

CAMPYLOBACTER CHEK™ test versus Culture

N = 1552	Culture Positive	Culture Negative
CAMPYLOBACTER CHEK™Positive	32	14*
CAMPYLOBACTER CHEK™Negative	3**	1503

		95% Confidence Limits
Sensitivity	91.4%	77.6% - 97.0%
Specificity	99.1%	98.5% - 99.5%

The 17 discrepant specimens were further characterized by additional testing at TECHLAB. This testing included an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing.

Eight of the 14 specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive with all tests.
- Two of the 14 specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive with the commercial EIA, in-house PCR, and bidirectional sequencing. Four specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive for C. upsaliensis (an important pathogen) by species-specific PCR and sequencing.
** One of the three specimens that were culture positive and CAMPYLOBACTER CHEK™ test negative was confirmed to be negative with all tests.

Retrospective Study

Supplemental testing was performed on 30 retrospective specimens. The patient ages ranged from less than 11 months to 74 years. All retrospective specimens were Campylobacter spp. culture positive and were further characterized as Campylobacter spp. positive by an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter spp., and species-specific identification), and bidirectional sequencing. These specimens were then tested in the CAMPYLOBACTER CHEK™ test. All 30 specimens tested positive for Campylobacter spp. by all methods, yielding 100% correlation with all test methods.

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Reproducibility

The reproducibility of the CAMPYLOBACTER CHEK™ test was determined using 8 human fecal samples coded to prevent their identification during testing. Testing was performed at 2 independent laboratories and on-site at TECHLAB. Inc. The samples were tested twice a day over a 5-day period by multiple technicians at each site using 2 different kit lots. Positive and negative controls were run with each panel of the masked samples. The results from each laboratory were submitted to TECHLAB, Inc. and compared with in-house results were consistent among the different locations and exhibited a correlation of 100%. The samples produced the expected results 100% of the time.

Analytical Sensitivity

The analytical sensitivity of the test was determined by using C. coli whole organism culture preparations in a sample matrix. The concentration of C. coll organisms in fecal matrix at which specimens are positive by the CAMPYLOBACTER CHEK™ test 95% of the time is the assay Limit of Detection (LoD).

The Limit of Detection (LoD) for the CAMPYLOBACTER CHEK™ test with raw fecal samples was established at 2.10 x 105 CFU/mL (4203 CFU/test) for C. jejuni. For specimens in Protocol™ Cary Blair media, the LoD was established at 8.06 x 105 CFU/mL (10072 CFU/test) for C. jejuni. For specimens in Protocol™ C&S media, the LoD was established at 5.09 x 105 CFU/mL (6357 CFU/test) for C. jejuni. The limits of detection are equivalent for both single and dual wavelength readings.

The Limit of Detection (LoD) for the CAMPYLOBACTER CHEK™ test with raw fecal samples was established at 1.57 x 10° CFU/mL (31324 CFU/test) for C. coli. For specimens in Protocol™ Cary Blair media, the LoD was established at 3.77 x 10 CFU/mL (47077 CFU/test) for C. coli. For specimens in Protocol™ C&S media, the LoD was established at 5.36 x 10° CFU/mL (66974 CFU/test) for C. coli. The limits of detection are equivalent for both single and dual wavelength readings.

Analytical Specificity (Cross Reactivity)

The CAMPYLOBACTER 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 CAMPYLOBACTER CHEK™ test.

Acinetobacter baumanniiBacillus subtilisCampylobacter fetusCitrobacter freundiiClostridium perfringensEnterococcus faecalis	Aeromonas hydrophilaBacteroides fragilisCampylobacter hyointestinalisClostridium bifermentansEdwardsiella tardaEscherichia coli	Bacillus cereusCampylobacter concisusCandida albicansClostridium difficileEnterobacter cloacaeEscherichia coli EIEC
Escherichia coli EPECEscherichia coli O157:H7 (non-toxigenic)Escherichia fergusoniiKlebsiella pneumoniaeListeria monocytogenesPorphyromonas asaccharolyticaPseudomonas aeruginosaSerratia marcescensShigella sonneiStreptococcus agalactiaeYersinia enterocolitica	Escherichia coli ETECEscherichia hermaniiLactobacillus acidophilusPeptostreptococcus anaerobiusPrevotella melaninogenicaPseudomonas fluorescensShigella dysenteriaeStaphylococcus aureusStaphylococcus epidermidis	Escherichia coli O157:H7 (toxigenic)Helicobacter pyloriLactococcus lactisPlesiomonas shigelloidesProteus vulgarisSalmonella enterica typhimuriumShigella flexneriStaphylococcus aureus (Cowan's)Vibrio parahaemolyticus
Adenovirus Type 1, 2, 3, 5, 40, 41Echovirus 9, 11, 18, 22, 33Human Rotavirus	Human CoronavirusEnterovirus 68, 69, 70, 71	Coxsackievirus B2, B3, B4, B5Norovirus

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Campylobacter species that were shown to be reactive with the CAMPYLOBACTER CHEK™ test.

C. helveticus (strain 54661) was found to be positive at 3.14 x 108 CFU/mL (2 x LoD of C. coll),
C. lari (strain 23947) was found to be positive at 1.26 x 107 CFU/mL (8 x LoD of C. coli), and
C. upsaliensis (strain 14913) was found to be positive at 3.14 x 10° CFU/mL (2x LoD of C. coll).

Inclusivity Study

The specificity of the CAMPYLOBACTER CHEK™ test was evaluated using several strains of Campylobacter iejuni and Campylobacter coli. All strains listed generated positive results when tested. C. coli CCUG strains: 11283, 10956, 17755, 36994, 53138*

C. jejuni sub-species jejuni CCUG strains: 11284, 6951, 12081, 29411, 38106

C. jejuni sub-species doylei CCUG strain: 24567

*Strain 53138 was positive at 4 x LoD.

Interfering Substances (U.S. Formulation)

The following substances had no effect on positive or negative CAMPYLOBACTER 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), Hvdrocortisone (1% w/v), Imodium® (5% v/v), Kaopectate® (5% v/v), Leukocytes (0.05% w/v), Maalox® Advanced (5% v/v), Mesalazine (10% w/v), Metronidazole (0.25% w/v), Mineral Oil (10% w/v), Mylanta® (4.2 mg/mL), Naproxen Sodium (5% w/v), Nonoxynol-9 (40% w/v), Nystatin (1% w/v), Palmitic Acid/Fecal Fat (40% w/v), Pepto-Bismol® (5% v/v), Phenylephrine (1% w/v), Polyethylene glycol 3350 (10% w/v ), Prilosec OTC® (5 µg/mL), Sennosides (1% w/v), Simethicone (10% w/v), Steric Acid/Fecal Fat (40% w/v), Tagamet® (5 µg/mL), TUMS® (50 µg/mL), Human Urine (5% v/v), and Vancomvcin (0.25% w/v).

Precision - Intra-assay

For the determination of intra-assay performance, 8 fecal samples were analyzed by the CAMPYLOBACTER CHEK™ test. The samples included 2 negative, 2 high negative, 2 low positive, and 2 moderate positive samples. Each sample was assayed a total of five times using two different kit lots. Positive specimens consistently tested positive and high negative specimens consistently tested negative. No difference was observed between the results for the single wavelength, dual wavelength and visual reading results. There was 100% agreement between the two kit lots.

Precision - Inter-assay

For the determination of inter-assay performance, 8 fecal samples were analyzed by the CAMPYLOBACTER CHEK™ test. The samples included 2 negative, 2 high negative, 2 low positive, and 2 moderate positive samples were tested twice a day by multiple technicians over a 12-day period using 2 different kit lots. All positive samples remained positive and all negative samples remained negative. Visual interpretation of results gave a correlation of 100% with spectrophotometric interpretation. Both kit lots exhibited a correlation of 100%.

Prozone

To ensure that a high concentration of Campylobacter antigen does not interfere with a positive reaction in the CAMPYLOBACTER CHEK™ test, high samples were prepared by spiking a negative fecal pool at a concentration possibly observed in clinical specimens. A total of 5 different dilutions of C. jejuni and C. coli whole organism culture preparation, up to and including the clinically observed high concentration, were 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.

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CONCLUSION

The conclusions drawn from the nonclinical and clinical tests demonstrate that the CAMPYLOBACTER CHEK™ test is as safe and as effective and performs as well or better than standard culture, and is 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).