(89 days)
The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
The H. PYLORI QUIK CHEK™ test utilizes antibodies specific for H. pylori antigen. The Membrane Device contains a Reaction Window with two vertical lines of immobilized antibodies. The test line ("T") contains antibodies specific for H, pylori antigen. The ("C") contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. To perform the test, the sample 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, any H. pylori antigen in the sample binds to the antibody-peroxidase conjugate. The antigen-antibody-peroxidase complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-H. pylori antigen antibodies in the test line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10-minute incubation period, the Reaction Window is examined visually for the appearance of vertical blue lines on the "C" and "T" sides of the Reaction Window. A blue line on the "T" side of the Reaction Window indicates a positive result. A positive "C" reaction, indicated by a vertical blue line on the "C" side of the Reaction Window, 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.
Here's an analysis of the acceptance criteria and study data for the H. PYLORI QUIK CHEK™ device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "sensitivity must be >90%"). Instead, the document presents the performance data and implies these values are acceptable for demonstrating substantial equivalence. The key performance metrics are Sensitivity and Specificity compared to a Composite Reference Method (CRM) for initial diagnosis, and Sensitivity for post-therapy. Also included are agreement rates from a retrospective study against an FDA-cleared ELISA, and analytical sensitivity (Limit of Detection).
| Acceptance Criteria (Implied from Study Results for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Initial Diagnosis (vs. CRM) | |
| Sensitivity: To demonstrate accurate detection of H. pylori infection. | 97.0% (95% CI: 84.7% - 99.5%) |
| Specificity: To demonstrate accurate identification of absence of H. pylori. | 100.0% (95% CI: 95.9% - 100.0%) |
| Post-Therapy (vs. CRM) | |
| Sensitivity: To demonstrate accurate detection of H. pylori persistence post-treatment. | 100.0% (95% CI: 70.1% - 100.0%) |
| Retrospective Study (vs. FDA Cleared Commercial ELISA) | |
| Positive Agreement: To demonstrate consistent positive results with predicate. | 98.9% (95% CI: 94.2% - 99.8%) |
| Negative Agreement: To demonstrate consistent negative results with predicate. | 97.2% (95% CI: 92.0% - 99.0%) |
| Analytical Sensitivity (Limit of Detection) | LoD for H. pylori antigen: 16.08 ng/mL in fecal matrix (0.24 ng/test). |
| LoD in Cary Blair media: 13.01 ng/mL (0.20 ng/test). | |
| LoD in C&S media: 19.96 ng/mL (0.31 ng/test). | |
| Reproducibility | 100% overall percent agreement across different locations, technicians, and kit lots. |
| Analytical Specificity (Cross Reactivity) | No interference observed with listed common intestinal organisms and viruses. |
| Inclusivity | All tested H. pylori strains (including ATCC 700392, ATCC 43526, ATCC 700824, JP26, ATCC 43504, ATCC 43579) generated a positive result. |
| Interfering Substances | No effect on positive results from listed substances at indicated concentrations. |
| Prozone Effect | No overall prozone effect observed; elevated antigen levels did not affect detection. |
2. Sample Size Used for the Test Set and Data Provenance
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Initial Diagnosis & Post-Therapy Study:
- Sample Size: 122 patients for initial diagnosis, 9 samples for post-therapy.
- Data Provenance: The study was conducted at 6 independent sites. It involved patients "undergoing endoscopy as part of routine care," suggesting prospective enrollment of clinical samples. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.
-
Retrospective Sample Study:
- Sample Size: 200 samples (94 positive and 106 negative by the commercial ELISA).
- Data Provenance: Retrospective study. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
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Initial Diagnosis & Post-Therapy Study:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was a Composite Reference Method (CRM) consisting of "rapid urease and histology of the biopsy samples." These methods are typically performed and interpreted by pathologists and gastroenterologists/endoscopists, but the specific number or qualifications of individuals involved in the CRM determination are not detailed.
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Retrospective Sample Study:
- Number of Experts: Not applicable, as ground truth was established by an "FDA cleared commercial ELISA."
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Initial Diagnosis & Post-Therapy Study: The document states "A composite reference method (CRM) comparison was used in the evaluation consisting of rapid urease and histology of the biopsy samples." This implies a combined clinical assessment, but the specific adjudication method (e.g., how discrepancies between rapid urease and histology were resolved, or if multiple readings were combined) is not detailed.
- Retrospective Sample Study: Adjudication was not involved as the comparison was against a single FDA-cleared commercial ELISA. PCR was used to further investigate discordant results, but this was for understanding discrepancies, not for establishing initial ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the device compared to a reference method, not on how human readers' performance improves with or without the device. The H. PYLORI QUIK CHEK™ is a laboratory test, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The entire clinical performance section (Initial Diagnosis, Post-Therapy) and the retrospective sample study describe the performance of the H. PYLORI QUIK CHEK™ test on its own, producing a qualitative (positive/negative) result, against an established ground truth or cleared predicate device. This is the standalone performance of the algorithm/device.
7. Type of Ground Truth Used
- Initial Diagnosis & Post-Therapy Study: Composite Reference Method (CRM) consisting of rapid urease and histology of biopsy samples.
- Retrospective Sample Study: An FDA cleared commercial ELISA. Discordant results were further investigated using H. pylori DNA amplification with PCR.
8. Sample Size for the Training Set
- The document does not explicitly mention a training set or details about its size. This is a diagnostic device (an enzyme immunoassay), not a software or AI algorithm that typically requires a distinct training phase on a dataset. The development of such a device involves optimizing reagents and protocols, which is a different process than machine learning algorithm training.
9. How the Ground Truth for the Training Set Was Established
- As a distinct "training set" for an algorithm is not described, the method for establishing ground truth for such a set is not applicable/not provided in this document. The device's components (antibodies, reagents) would have been developed and validated through internal R&D processes, likely using characterized H. pylori samples and controls, but this isn't presented as a formal "training set" in the context of this 510(k) summary.
§ 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).