CAMPYLOBACTER QUIK CHEK

K173217 · Techlab, Inc. · LQP · Jan 22, 2018 · Microbiology

Device Facts

• Record ID: K173217
• Device Name: CAMPYLOBACTER QUIK CHEK
• Applicant: Techlab, Inc.
• Product Code: LQP · Microbiology
• Decision Date: Jan 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK 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 Story

Rapid membrane enzyme-linked immunosorbent assay (ELISA) for qualitative detection of Campylobacter-specific antigens in human fecal specimens; detects C. jejuni and C. coli. Input: fecal specimen (unpreserved or in transport media) mixed with diluent and antibody-peroxidase conjugate. Operation: sample-conjugate mixture added to cassette; antigen-antibody complexes migrate through filter pad to membrane; captured by immobilized anti-Campylobacter antibodies; washed; substrate added. Output: visual blue line in 'T' (test) and 'C' (control) windows. Used in clinical settings; performed by laboratory personnel. Results interpreted visually by clinician; used alongside clinical findings/patient history to guide treatment for gastroenteritis. Benefits: rapid results (<30 mins) compared to 48-72 hour culture; does not require bacterial viability; allows testing of samples exposed to air.

Clinical Evidence

Prospective clinical study (N=1552) compared device to culture. Sensitivity 97.1% (95% CI: 85.5% - 99.9%), specificity 99.1% (95% CI: 98.5% - 99.5%). Discrepant analysis using commercial EIA, molecular tests, and sequencing confirmed 13/14 culture-negative/device-positive samples as true positives. Retrospective study (N=30) showed 100% correlation with culture and molecular methods. Reproducibility study across 3 sites showed 100% correlation. Analytical sensitivity (LoD) and specificity (cross-reactivity) established; no prozone effect observed.

Technological Characteristics

Rapid membrane enzyme-linked immunosorbent assay (ELISA) in single-use cassette format. Employs monoclonal/polyclonal antibodies against Campylobacter-specific antigen. Conjugate: antibody coupled to horseradish peroxidase. Substrate: tetramethylbenzidine. Internal control: anti-IgG antibody line. Storage: 2°C – 8°C. Manual, bench-top operation.

Indications for Use

Indicated for qualitative detection of Campylobacter-specific antigen (C. jejuni and C. coli) in human fecal specimens from patients with signs and symptoms of gastroenteritis.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter 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.

Predicate Devices

• ImmunoCard STAT! CAMPY (K090700)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

January 22, 2018

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

Re: K173217

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

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. 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 ([e-mail]) or phone [phone] 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) K173217

Device Name CAMPYLOBACTER QUIK CHEK

#### Indications for Use (Describe)

The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK 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) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:120%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## CAMPYLOBACTER 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: | January 22, 2018 |
|----------------|---------------------------------------------------------------------------|
| Name: | TECHLAB, Inc. |
| Address: | 2001 Kraft Drive<br>Corporate Research Center<br>Blacksburg, VA 24060 USA |

| Contact Person: | Donna T. Link |
|-----------------|-------------------|
| Phone Number: | 540-953-1664 |
| Email: | [e-mail] |

#### 1.1 Manufacturing Facility Address

TECHLAB, Inc. 20 Corporate Drive Radford, VA 24141 USA

#### 1.2 Product and Trade Name of the Device

CAMPYLOBACTER QUIK 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

83 Microbiology

#### 1.7 Reason for Premarket Notification

The development of a new rapid membrane enzyme immunoassay for the qualitative detection of Campylobacter spp. in a single use cassette.

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## Intended Use

The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK 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.

## Explanation

Worldwide, Campylobacter species are the most common cause of bacterial gastroenteritis, with 400-500 million cases of diarrhea each vear. 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. jeiuni 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.g., 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 slow-growing, requiring from 48-72 hours before reaching a point where the culture can safely be reported as negative. Such delays can leave the clinician in a quandary and the patient with non-specific, ineffective, or even inappropriate treatment.

The CAMPYLOBACTER QUIK CHEK™ test allows detection of Campylobacter jejuni and Campylobacter coli, the species most commonly associated with human disease, in less than 30 minutes. Furthermore, the CAMPYLOBACTER QUIK 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 QUIK CHEK™ test uses antibodies that recognize a Campylobacterspecific antigen in human fecal samples. The device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies against a Campylobacterspecific antigen. The control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibodies to a Campylobacter-specific antigen coupled to horseradish peroxidase. To perform the test, a fecal specimen 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, the Campylobacter-specific antigens in the sample bind to the antibody-peroxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-Campylobacter antibodies in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation, the "T" reaction is examined visually for the appearance of a vertical blue line. A blue line indicates a positive "C" reaction, indicated by a vertical blue line, monitors/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

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Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.

## Materials Provided

- Membrane Devices 25, each pouch contains 1 device ●
- Conjugate (2.5 mL) Antibody to a Campylobacter-specific antigen coupled to horseradish ● peroxidase in a buffered protein solution
- Diluent (22 mL) Buffered protein solution with graduated dropper assembly ●
- . Positive Control (2 mL) - Campylobacter-specific antigen in a buffered protein solution
- Wash Buffer (12 mL) Buffered solution with graduated dropper assembly .
- Substrate (3.5 mL) Solution containing tetramethylbenzidine ●
- . Disposable plastic transfer pipettes - graduated at 25 µL, 100 µL, 200 µL, 300 µL, 400 µL and 500 µL

The predicate device (ImmunoCard STAT!® CAMPY) and the CAMPYLOBACTER QUIK CHEK™ test both detect Campylobacter spp. (C. jejuni and C. col) in fecal specimens and are substantially equivalent in principle. The following table shows a comparison of both devices.

| Similarities | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device<br>K173217 | Predicate<br>K090700 |
| Indications for use | The CAMPYLOBACTER QUIK CHEK™<br>test is a rapid membrane enzyme-linked<br>immunosorbent assay for the qualitative<br>detection of a Campylobacter-specific<br>antigen in human fecal specimens. The<br>CAMPYLOBACTER QUIK CHEK test is<br>designed to detect C. jejuni and C. coli<br>from patients with symptoms of<br>gastroenteritis. The test is intended for<br>use with unpreserved human fecal<br>specimens and fecal specimens that are<br>in transport media. Test results should<br>be considered in conjunction with clinical<br>findings and patient history. | ImmunoCard STAT! CAMPY is an<br>immunochromatographic rapid test for<br>the qualitative detection of specific<br>Campylobacter antigens in human<br>stool. ImmunoCard STAT! CAMPY<br>detects C. jejuni and C. coli in human<br>stool, where stool may be either<br>unpreserved or preserved in Cary-<br>Blair-based transport media. Test<br>results are to be used in conjunction<br>with information available from the<br>patient clinical evaluation and other<br>diagnostic procedures. |
| Measured analyte | Detection of Campylobacter-specific<br>antigens (C. jejuni and C. coli) | Detection of Campylobacter-specific<br>antigens (C. jejuni and C. coli) |
| Type of Test | Qualitative | Same |
| Controls | Positive and negative control included in<br>the kit Internal "C" Control line | Same |
| Format | Single Use Membrane Cassette | Same |
| Target<br>Population | Persons suspected of having<br>Campylobacter infection | Same |
| Storage | Refrigerated (2°C – 8°C) | Same |

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There are no differences between the subject device and the predicate(s) with respect to indications and intended use.

| Differences | | |
|-----------------|----------------------------------------------------------|---------------------------------------------------|
| Item | Device<br>K173217 | Predicate<br>K090700 |
| Specimen Type | Fecal specimens in Cary-Blair and<br>C&S Transport Media | Fecal specimens in Cary-<br>Blair Transport Media |
| Time to Result | <30 minutes | < 25 minutes |
| Antibody Format | Monoclonal/Polyclonal | Monoclonal/Monoclonal |

### Summary of Performance Data

#### Prospective Study

The performance of the CAMPYLOBACTER QUIK CHEK™ test was evaluated at 4 independent sites. Prospective incoming fecal specimens were collected and tested by culture and the CAMPYLOBACTER QUIK CHEK™ test. The following table shows a summary of the clinical performance of the CAMPYLOBACTER QUIK CHEK™ test for all 4 sites combined. The results of the study show that the CAMPYLOBACTER QUIK CHEK™ test exhibited a sensitivity of 97.1%, 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 QUIK CHEK™ test versus Culture

| N = 1552 | Culture Positive | Culture Negative |
|--------------------------------------|------------------|------------------|
| CAMPYLOBACTER QUIK CHEK™<br>Positive | 34 | 13* |
| CAMPYLOBACTER QUIK CHEK™<br>Negative | 1** | 1504 |

| | | 95% Confidence Limits |
|-------------|-------|-----------------------|
| Sensitivity | 97.1% | 85.5% - 99.9% |
| Specificity | 99.1% | 98.5% - 99.5% |

The 14 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, inhouse PCR (detecting the 16s rRNA gene of Campylobacter specific identification), and bidirectional sequencing.

* Nine of the 13 specimens that were culture negative and CAMPYLOBACTER QUIK CHEK™ test positive were confirmed to be positive for C. jejuni with all test methods.

Two of the 13 specimens that were culture negative and CAMPYLOBACTER QUIK CHEK™ test positive were confirmed to be positive with the commercial EIA, in-house PCR, and bidirectional sequencing.

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One of the 13 specimens that was culture negative and CAMPYLOBACTER QUIK CHEK™ test positive was confirmed to be positive with an FDA-cleared commercial molecular test, in-house PCR and bidirectional sequencing.

One specimen that was culture negative and CAMPYLOBACTER QUIK CHEK™ test positive was confirmed to be positive for C. upsaliensis (an important pathogen) by species-specific PCR and sequencina.

** The one specimen that was culture positive and CAMPYLOBACTER QUIK CHEK™ test negative was confirmed to be negative for C. jejuni or C. coli with all test methods.

#### 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 QUIK CHEK™ test. All 30 specimens tested positive for Campylobacter spp. by all methods, yielding 100% correlation with all test methods.

#### Reproducibility

The reproducibility of the CAMPYLOBACTER QUIK CHEK™ test was determined using 8 fecal specimens that were coded to prevent their identification during testing. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The samples included 2 negative samples, 2 high negative samples, 2 low positive samples and 2 moderate positive samples. 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. A positive and negative control was run with each panel of the masked samples. The results from each laboratory were submitted to TECHLAB, Inc. and compared with in-house results. The 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. jejuni and C. coli whole organism culture preparations in a sample matrix. The concentration of C. jejuni and C. coli organisms in fecal matrix at which specimens are positive by the CAMPYLOBACTER QUIK CHEK™ test 95% of the time is the assay Limit of Detection (LoD).

The Limit of Detection (LoD) for the CAMPYLOBACTER QUIK CHEK™ test with raw fecal samples was established at 8.39 x 104 CFU/mL (1271 CFU/test) for C. jejuni. For specimens in Protocol™ Cary Blair media, the LoD was established at 1.78 x 108 CFU/mL (2781 CFU/test) for C. jejuni. For specimens in Protocol™ C&S media, the LoD was established at 7.25 x 104 CFU/mL (1133 CFU/test) for C. jejuni.

The Limit of Detection (LoD) for the CAMPYLOBACTER QUIK CHEK™ test with raw fecal samples was established at 7.70 x 108 CFU/mL (11667 CFU/test) for C. coli. For specimens in Protocol™ Cary Blair media, the LoD was established at 2.22 x 10° CFU/mL (34688 CFU/test) for C. coli. For specimens in Protocol™ C&S media, the LoD was established at 1.56 x 10° CFU/mL (24375 CFU/test) for C. coli.

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## Analytical Specificity (Cross Reactivity)

The CAMPYLOBACTER 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 CAMPYLOBACTER QUIK CHEK™ test.

| Acinetobacter baumannii | Aeromonas hydrophila | Bacillus cereus |
|------------------------------------------------|------------------------------------------|-------------------------------|
| Bacillus subtilis | Bacteroides fragilis | Campylobacter concisus |
| Campylobacter fetus | Candida albicans | Citrobacter freundii |
| 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) | Escherichia hermanii |
| Escherichia coli O157:H7 (toxigenic) | Escherichia fergusonii | Lactobacillus acidophilus |
| Helicobacter pylori | Klebsiella pneumoniae | Peptostreptococcus anaerobius |
| Lactococcus lactis | Listeria monocytogenes | Prevotella melaninogenica |
| Plesiomonas shigelloides | Porphyromonas asaccharolytica | Pseudomonas fluorescens |
| Proteus vulgaris | Pseudomonas aeruginosa | Shigella dysenteriae |
| Salmonella enterica typhimurium | Serratia marcescens | Staphylococcus aureus |
| Shigella flexneri | Shigella sonnei | Staphylococcus epidermidis |
| Staphylococcus aureus (Cowan's) | Streptococcus agalactiae | Coxsackievirus B2, B3, B4, B5 |
| Vibrio parahaemolyticus | Yersinia enterocolitica | Norovirus |
| Adenovirus Type 1, 2, 3, 5, 40, 41 | Human Coronavirus | |
| Echovirus 9, 11, 18, 22, 33<br>Human Rotavirus | Enterovirus 68, 69, 70, 71 | |

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

C. helveticus (strain 54661) was found to be positive at 3.08 x 10° CFU/mL (4 x LoD of C. coli)

C. lari (strain 23947) was found to be positive at 3.08 x 10° CFU/mL (4 x LoD of C. coll)

C. upsaliensis (strain 14913) was found to be positive at 1.54 x 10° CFU/mL (2 x LoD of C. col)

## Inclusivity Study

The specificity of the CAMPYLOBACTER QUIK CHEK™ test was evaluated using several strains of Campylobacter jejuni and Campylobacter coli. All strains listed generated positive results when tested.

C. coli strains: 11283, 10956, 17755, 36994, 53138

- C. jejuni sub-species jejuni strains: 11284, 6951, 12081, 29411, 38106
C. jejuni sub-species doylei strain: 24567

## Interfering Substances (U.S. Formulation)

The following substances had no effect on positive or negative CAMPYLOBACTER 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% 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 ug/mL), TUMS® (50 µg/mL), Human Urine (5% v/v), and Vancomvcin (0,25% w/v),

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## Prozone

To ensure that a high concentration of Campylobacter antigen does not interfere with a positive reaction in the CAMPYLOBACTER QUIK CHEK™ test, high positive 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.

## CONCLUSION

The conclusions drawn from the nonclinical and clinical tests demonstrate that the CAMPYLOBACTER QUIK 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.