(111 days)
No
The device description details a traditional enzyme-linked immunosorbent assay (ELISA) with visual interpretation of results, and there is no mention of AI or ML in the document.
No
The device is a diagnostic test kit designed to detect an antigen, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is for the "qualitative detection of a Campylobacter-specific antigen in human fecal specimens" and is "designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis." This indicates its purpose is to help identify a medical condition, which is the definition of a diagnostic device.
No
The device description clearly outlines a physical, in-vitro diagnostic test kit involving antibodies, membranes, reagents, and visual examination of a reaction window. There is no mention of software as the primary or sole component of the device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test is for the "qualitative detection of a Campylobacter-specific antigen in human fecal specimens." This is a classic definition of an in vitro diagnostic test, as it is performed on a sample taken from the human body to provide information about a medical condition.
- Device Description: The description details a laboratory-based assay using antibodies and enzymatic reactions to detect an analyte (Campylobacter antigen) in a biological sample (fecal specimen). This is consistent with the nature of IVD devices.
- Performance Studies: The document includes detailed performance studies (Prospective and Retrospective) evaluating the test's sensitivity and specificity against reference methods (culture, EIA, molecular tests). This type of validation is required for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (ImmunoCard STAT!® CAMPY, K090700) indicates that this device is being compared to an existing, cleared IVD device, which is a common pathway for regulatory clearance of new IVDs.
- Anatomical Site: The test is performed on "human fecal specimens," which are biological samples taken from the human body.
All of these factors strongly indicate that the CAMPYLOBACTER QUIK CHEK™ test is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LQP
Device Description
The CAMPYLOBACTER QUIK CHEK™ test uses antibodies that recognize a Campylobacter-specific 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 Campylobacter-specific 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 Membrane Device. It also confirms the reactivity of the other reagents associated with the assay and that the results are valid.
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.
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: Fecal specimens collected from 4 independent sites.
- Annotation Protocol: Specimens were tested by both culture and the CAMPYLOBACTER QUIK CHEK™ test. Discrepant specimens were further characterized by additional testing at TECHLAB, including 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: Specimens that were Campylobacter spp. culture positive.
- Annotation Protocol: All retrospective 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. These specimens were then tested in the CAMPYLOBACTER QUIK CHEK™ test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Prospective Study:
- Study Type: Clinical Performance Evaluation
- Sample Size: N = 1552
- Standalone Performance: The CAMPYLOBACTER QUIK CHEK™ test exhibited a sensitivity of 97.1%, and a specificity of 99.1% with culture.
- Key Results:
- 9 of 13 specimens that were culture negative and CAMPYLOBACTER QUIK CHEK™ test positive were confirmed positive for C. jejuni with all test methods.
- 2 of 13 specimens that were culture negative and CAMPYLOBACTER QUIK CHEK™ test positive were confirmed positive with commercial EIA, in-house PCR, and bidirectional sequencing.
- 1 of 13 specimens that was culture negative and CAMPYLOBACTER QUIK CHEK™ test positive was confirmed positive with an FDA-cleared commercial molecular test, in-house PCR and bidirectional sequencing.
- 1 specimen that was culture negative and CAMPYLOBACTER QUIK CHEK™ test positive was confirmed positive for C. upsaliensis by species-specific PCR and sequencing.
- 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:
- Study Type: Supplemental Testing
- Sample Size: 30 retrospective specimens
- Key Results: All 30 specimens tested positive for Campylobacter spp. by all methods, yielding 100% correlation with all test methods.
Reproducibility:
- Study Type: Reproducibility Study
- Sample Size: 8 fecal specimens (2 negative, 2 high negative, 2 low positive, 2 moderate positive)
- Key Results: The results were consistent among the different locations (2 independent laboratories and TECHLAB, Inc.), and exhibited a correlation of 100%. The samples produced the expected results 100% of the time.
Analytical Sensitivity:
- Study Type: Limit of Detection (LoD) Study
- Key Results:
- LoD for C. jejuni in raw fecal samples: 8.39 x 10^4 CFU/mL (1271 CFU/test)
- LoD for C. jejuni in Protocol™ Cary Blair media: 1.78 x 10^8 CFU/mL (2781 CFU/test)
- LoD for C. jejuni in Protocol™ C&S media: 7.25 x 10^4 CFU/mL (1133 CFU/test)
- LoD for C. coli in raw fecal samples: 7.70 x 10^8 CFU/mL (11667 CFU/test)
- LoD for C. coli in Protocol™ Cary Blair media: 2.22 x 10^9 CFU/mL (34688 CFU/test)
- LoD for C. coli in Protocol™ C&S media: 1.56 x 10^9 CFU/mL (24375 CFU/test)
Analytical Specificity (Cross Reactivity) and Inclusivity Study:
- Study Type: Cross-Reactivity and Inclusivity Evaluation
- Key Results:
- None of the common intestinal organisms or viruses tested interfered with the performance.
- C. helveticus, C. lari, and C. upsaliensis were found to be positive at specific concentrations.
- All tested strains of Campylobacter jejuni and Campylobacter coli generated positive results.
Interfering Substances:
- Study Type: Interference Study
- Key Results: The listed substances had no effect on positive or negative CAMPYLOBACTER QUIK CHEK™ test results at the indicated concentrations.
Prozone:
- Study Type: Prozone Effect Evaluation
- Key Results: There was no overall prozone effect; elevated levels of antigen did not affect the detection of the antigen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 97.1%, 95% Confidence Limits: 85.5% - 99.9%
Specificity: 99.1%, 95% Confidence Limits: 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, 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.
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
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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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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 |
| 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 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.
4
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
5
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 | |
| K173217 | Predicate | |
| K090700 | ||
| 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 symptoms of | ||
| gastroenteritis. The test is intended for | ||
| use with unpreserved human fecal | ||
| specimens and fecal specimens that are | ||
| in transport media. Test results should | ||
| be considered in conjunction with clinical | ||
| findings and patient history. | ImmunoCard STAT! CAMPY is an | |
| immunochromatographic rapid test for | ||
| the qualitative detection of specific | ||
| Campylobacter antigens in human | ||
| stool. ImmunoCard STAT! CAMPY | ||
| detects C. jejuni and C. coli in human | ||
| stool, where stool may be either | ||
| unpreserved or preserved in Cary- | ||
| Blair-based transport media. Test | ||
| results are to be used in conjunction | ||
| with information available from the | ||
| patient clinical evaluation and other | ||
| diagnostic procedures. | ||
| Measured analyte | Detection of Campylobacter-specific | |
| antigens (C. jejuni and C. coli) | Detection of Campylobacter-specific | |
| antigens (C. jejuni and C. coli) | ||
| Type of Test | Qualitative | Same |
| Controls | Positive and negative control included in | |
| the kit Internal "C" Control line | Same | |
| Format | Single Use Membrane Cassette | Same |
| Target | ||
| Population | Persons suspected of having | |
| 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 | |
| K173217 | Predicate | |
| K090700 | ||
| Specimen Type | Fecal specimens in Cary-Blair and | |
| C&S Transport Media | Fecal specimens in Cary- | |
| Blair Transport Media | ||
| Time to Result |