(111 days)
Not Found
No
The device description and performance studies detail a standard enzyme immunoassay (EIA) for antigen detection, with no mention of AI/ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic test designed to detect a Campylobacter-specific antigen; it does not treat or cure a disease or condition.
Yes
The CAMPYLOBACTER CHEK™ test is designed for the qualitative detection of a Campylobacter-specific antigen from human fecal specimens to aid in the diagnosis of gastroenteritis, which aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical kit with components like a Microassay Plate, Conjugate, and Substrate, indicating it is an in vitro diagnostic test with hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of a Campylobacter-specific antigen in human fecal specimens." This is a diagnostic test performed in vitro (outside the body) on a biological sample.
- Device Description: The description details an "enzyme immunoassay" which is a common method used in IVD tests to detect specific substances in biological samples.
- Anatomical Site: The test is performed on "Human fecal specimens," which are biological samples collected from the body for analysis.
- Performance Studies: The document includes detailed performance studies (sensitivity, specificity, analytical sensitivity, analytical specificity, etc.) which are standard requirements for demonstrating the performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device" (K083464; Premier® CAMPY) is a strong indicator that this device is being compared to an existing, cleared IVD device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human fecal specimens
Indicated Patient Age Range
The ages ranged from less than 1 year to 100 years. Of the 1552 patients, 15.7% were ≤ 18 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
Prospective Study:
- Sample Size: 1552 patients
- Data Source: Prospective incoming fecal specimens collected at 4 independent sites.
- Annotation Protocol: Specimens were tested by both culture and the CAMPYLOBACTER CHEK™ test. Discrepant specimens underwent additional testing by 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.
Retrospective Study:
- Sample Size: 30 retrospective specimens
- Data Source: All retrospective specimens were Campylobacter spp. culture positive.
- Annotation Protocol: These specimens 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. They were then tested with the CAMPYLOBACTER CHEK™ test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Prospective Study:
- Study Type: Prospective clinical evaluation.
- Sample Size: 1552 patients.
- Standalone performance: Sensitivity: 91.4%, Specificity: 99.1%.
- Key Results: The CAMPYLOBACTER CHEK™ test exhibited a sensitivity of 91.4%, and a specificity of 99.1% with culture. Eight of 14 culture-negative, CAMPYLOBACTER CHEK™ positive specimens were confirmed positive by all additional tests. Two of 14 were confirmed positive by commercial EIA, in-house PCR, and bidirectional sequencing. Four of 14 were confirmed positive for C. upsaliensis by species-specific PCR and sequencing. One of 3 culture-positive, CAMPYLOBACTER CHEK™ negative specimens was confirmed negative by all additional tests.
- Retrospective Study:
- Study Type: Supplemental testing with retrospective specimens.
- Sample Size: 30 specimens.
- Key Results: All 30 specimens tested positive for Campylobacter spp. by all methods, yielding 100% correlation with all test methods (CAMPYLOBACTER CHEK™ vs. culture, commercial EIA, commercial molecular test, in-house PCR, and bidirectional sequencing).
- Reproducibility:
- Study Type: Multi-site reproducibility study.
- Sample Size: 8 human fecal samples.
- Key Results: Samples produced expected results 100% of the time, and results were consistent among different locations, exhibiting a correlation of 100%.
- Analytical Sensitivity (Limit of Detection - LoD):
- Study Type: LoD determination using C. coli whole organism culture preparations in a sample matrix.
- Key Results:
- C. jejuni: Raw fecal samples: 2.10 x 10^5 CFU/mL (4203 CFU/test); Protocol™ Cary Blair media: 8.06 x 10^5 CFU/mL (10072 CFU/test); Protocol™ C&S media: 5.09 x 10^5 CFU/mL (6357 CFU/test).
- C. coli: Raw fecal samples: 1.57 x 10^6 CFU/mL (31324 CFU/test); Protocol™ Cary Blair media: 3.77 x 10^6 CFU/mL (47077 CFU/test); Protocol™ C&S media: 5.36 x 10^6 CFU/mL (66974 CFU/test).
- Equivalent for single and dual wavelength readings.
- Analytical Specificity (Cross Reactivity):
- Study Type: Evaluation with common intestinal organisms and viruses.
- Key Results: None of the organisms or viruses tested interfered with the performance of the CAMPYLOBACTER CHEK™ test.
- Reactive Campylobacter species: C. helveticus, C. lari, C. upsaliensis were found to be positive at specific concentrations.
- Inclusivity Study:
- Study Type: Evaluation with various strains of Campylobacter jejuni and Campylobacter coli.
- Key Results: All listed C. coli and C. jejuni strains generated positive results when tested.
- Interfering Substances:
- Study Type: Evaluation of common substances for interference.
- Key Results: Barium sulfate, Benzalkonium Chloride, Ciprofloxacin, Ethanol, Hog gastric mucin, Human blood, Hydrocortisone, Imodium®, Kaopectate®, Leukocytes, Maalox® Advanced, Mesalazine, Metronidazole, Mineral Oil, Mylanta®, Naproxen Sodium, Nonoxynol-9, Nystatin, Palmitic Acid/Fecal Fat, Pepto-Bismol®, Phenylephrine, Polyethylene glycol 3350, Prilosec OTC®, Sennosides, Simethicone, Steric Acid/Fecal Fat, Tagamet®, TUMS®, Human Urine, and Vancomycin had no effect on results at indicated concentrations.
- Precision - Intra-assay:
- Study Type: Analysis of 8 fecal samples.
- Sample Size: 8 fecal samples (2 negative, 2 high negative, 2 low positive, 2 moderate positive), each assayed 5 times using 2 kit lots.
- Key Results: Positive specimens consistently positive, high negative specimens consistently negative. 100% agreement between two kit lots.
- Precision - Inter-assay:
- Study Type: Analysis of 8 fecal samples over time.
- Sample Size: 8 fecal samples (2 negative, 2 high negative, 2 low positive, 2 moderate positive), tested twice a day by multiple technicians over 12 days using 2 kit lots.
- Key Results: All positive samples remained positive, all negative samples remained negative. Visual interpretation had 100% correlation with spectrophotometric interpretation. Both kit lots exhibited 100% correlation.
- Prozone:
- Study Type: Evaluation of high antigen concentrations.
- Key Results: No overall prozone effect observed; elevated levels of antigen did not affect detection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity: 91.4%
- Specificity: 99.1%
- 95% Confidence Limits for Sensitivity: 77.6% - 97.0%
- 95% Confidence Limits for Specificity: 98.5% - 99.5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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, with the word "ADMINISTRATION" underneath.
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.
1
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
2
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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3
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 Drive |
| Corporate Research Center | |
| Blacksburg, VA 24060 USA |
| Contact Person: | Donna T. Link |
|---|---|
| Phone Number: | 540-953-1664 |
| Email: | dlink@techlab.com |
1.1 Manufacturing Facility Address
TECHLAB, Inc. 20 Corporate Drive Radford, VA 24141 USA
1.2 Product and Trade Name of the Device
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.
4
Intended Use
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.
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
5
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 | Device | |
| K173219 | Predicate | |
| K083464 | ||
| Indications for use | 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 symptoms of | ||
| gastroenteritis.The test is intended for | ||
| use with preserved fecal specimens in | ||
| transport media and unpreserved | ||
| human fecal specimens. Test results | ||
| should be considered in conjunction | ||
| with clinical findings and patient | ||
| history. | Premier CAMPY enzyme | |
| immunoassay (EIA) is an in | ||
| vitro qualitative procedure for | ||
| the detection of specific | ||
| Campylobacter antigens in | ||
| stool samples from patients | ||
| with signs and symptoms of | ||
| gastroenteritis. Premier | ||
| CAMPY detects C. jejuni and | ||
| C. coli in human stool that | ||
| may be either unpreserved or | ||
| preserved in Cary Blair-based | ||
| transport media. Test results | ||
| are to be used in conjunction | ||
| with information obtained | ||
| from the patient's clinical | ||
| evaluation and other | ||
| diagnostic procedures. | ||
| Premier CAMPY is | ||
| intended for use in hospital, | ||
| reference or state laboratory | ||
| settings. The device is not | ||
| intended for point-of-care | ||
| use. | ||
| Measured analyte | Detection of Campylobacter- | |
| specific antigens (C. jejuni and C. coli) | Same | |
| Specimen Type | Fecal specimens in Cary-Blair and | |
| C&S Transport Media | Same |
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| Similarities | ||
|---|---|---|
| Item | Device | |
| K173219 | Predicate | |
| K083464 | ||
| Type of Test | Qualitative | Same |
| Controls | Positive and negative control | |
| included in the kit | Same | |
| Target | ||
| Population | Persons suspected of having | |
| Campylobacter infection | Same | |
| Storage (kit) | Refrigerated (2°C – 8°C) | Same |
| Reading Method | Visual, Spectrophotometric | Same |
| Differences | ||
|---|---|---|
| Item | Device | |
| K173219 | Predicate | |
| K083464 | ||
| Time to Result | ~1 hour | ~2 hours |
| Antibody Format | Monoclonal/Polyclonal | Monoclonal/Monoclonal |
| Endpoint | ||
| determinations (dual | ||
| wavelength) | ≥ 0.120 | ≥ 0.100 |
| Endpoint | ||
| determinations (single | ||
| wavelength) | ≥ 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 baumannii
Bacillus subtilis
Campylobacter fetus
Citrobacter freundii
Clostridium perfringens
Enterococcus faecalis | Aeromonas hydrophila
Bacteroides fragilis
Campylobacter hyointestinalis
Clostridium bifermentans
Edwardsiella tarda
Escherichia coli | Bacillus cereus
Campylobacter concisus
Candida albicans
Clostridium difficile
Enterobacter cloacae
Escherichia coli EIEC |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Escherichia coli EPEC
Escherichia coli O157:H7 (non-toxigenic)
Escherichia fergusonii
Klebsiella pneumoniae
Listeria monocytogenes
Porphyromonas asaccharolytica
Pseudomonas aeruginosa
Serratia marcescens
Shigella sonnei
Streptococcus agalactiae
Yersinia enterocolitica | Escherichia coli ETEC
Escherichia hermanii
Lactobacillus acidophilus
Peptostreptococcus anaerobius
Prevotella melaninogenica
Pseudomonas fluorescens
Shigella dysenteriae
Staphylococcus aureus
Staphylococcus epidermidis | Escherichia coli O157:H7 (toxigenic)
Helicobacter pylori
Lactococcus lactis
Plesiomonas shigelloides
Proteus vulgaris
Salmonella enterica typhimurium
Shigella flexneri
Staphylococcus aureus (Cowan's)
Vibrio parahaemolyticus |
| Adenovirus Type 1, 2, 3, 5, 40, 41
Echovirus 9, 11, 18, 22, 33
Human Rotavirus | Human Coronavirus
Enterovirus 68, 69, 70, 71 | Coxsackievirus B2, B3, B4, B5
Norovirus |
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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.