(127 days)
The MERETEK UBT® Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
For administration by health care professionals. To be administered under a physician's supervision.
The device is a combination kit diagnostic drug/device composed of the following principle components: Test Meal (of approximately 220 calories), Pranactin Diagnostic Drug Dosage, Sterile Water, Breath Bag, Evacuated Breath Specimen Collection Tubes. In the MERETEK UBT® Breath Test for H. pylori, 125 mg of reconstituted 13C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori, 13Curea is decomposed to 13CO2 and NH4+. The 13CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in a TEST breath sample compared to a BASELINE sample taken before the Pranactin® solution was consumed. Analysis of the breath samples is performed by Gas Isotope Ratio Mass Spectrometry ("GIRMS").
Here's a breakdown of the acceptance criteria and study details for the MERETEK UBT® Breath Test for H.pylori, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "Sensitivity must be >= X%"). Instead, it presents the device's performance characteristics as "results" in comparison with established diagnostic methods. The implicit acceptance is based on the reported sensitivities and specificities, which are deemed sufficient by the FDA for the device's intended use.
Here's a table summarizing the reported device performance compared to various ground truth methods:
| Criteria/Comparison | Reported Device Performance (Sensitivity) | Reported Device Performance (Specificity) |
|---|---|---|
| Initial Diagnosis - Comparison with CLOtest® | 92.8% (95% CI: 89.9, 95.0) | 94.1% (95% CI: 71.3, 99.9) |
| Initial Diagnosis - Comparison with Histology | 95.2% (95% CI: 92.6, 97.0) | 90.0% (95% CI: 73.5, 97.9) |
| Initial Diagnosis - Comparison with Combined Endoscopic Methods | 95.2% (95% CI: 92.6, 97.0) | 89.7% (95% CI: 72.6, 97.8) |
| Post-Treatment Monitoring (1-6 Months Combined) | 95.5% (95% CI: 93.0, 97.2) | 96.0% (95% CI: 93.0, 98.0) |
| Negative Predictive Value (NPV) for Post-Treatment Monitoring (90% treatment efficacy) | >99% | N/A |
| Negative Predictive Value (NPV) for Post-Treatment Monitoring (50% treatment efficacy) | >95% | N/A |
Study Details
1. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Initial Diagnosis): The tables show different totals depending on the comparison method:
- Comparison with CLOtest®: 445 patients
- Comparison with Histology: 444 patients
- Comparison with Combined Endoscopic Methods: 444 patients
- Sample Size (Post-Treatment Monitoring):
- 1 Month EOT: 295 patients
- 3 Months EOT: 222 patients
- 6 Months EOT: 178 patients
- 1-6 Months Combined: 495 patients (sum of positive and negative cases; the total number of unique patients is not explicitly stated as the sum of EOT, but it's derived from the combined table entries.)
- Data Provenance: The studies included "499 adult patients with duodenal ulcer disease at 75 clinical sites in the United States." The data is prospective as patients were followed through various post-treatment intervals. It is described as "two (2) independent double blind clinical field trials."
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the specific "number of experts" or their detailed "qualifications" (e.g., "radiologist with 10 years of experience") for establishing the ground truth. However, it indicates that the ground truth methods used were:
- CLOtest®: A rapid urease test, typically read by laboratory personnel or clinicians.
- Histopathology: Involves microscopic examination of tissue samples, performed by pathologists.
- Microbiological culture: Growing bacteria from samples, performed by microbiologists.
These methods inherently require expertise in their respective fields (pathology, microbiology, and clinical interpretation of rapid tests).
3. Adjudication Method for the Test Set
The document describes the ground truth for initial diagnosis as being established by comparing the MERETEK UBT® Breath Test results with:
- CLOtest®
- Histology
- Combined endoscopic method results (CLOtest®, histology, and culture) per DAIDP guidelines.
For post-treatment monitoring, the ground truth was established by comparing the MERETEK UBT® Breath Test results with:
- Combined endoscopic methods (histology and culture) per DAIDP guidelines.
The specific "adjudication method" beyond using these combined references (e.g., a "2+1" rule for discordant results between the ground truth components) is not explicitly stated. It implies that the combined methods served as the reference standard.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study's focus was on the stand-alone performance of the MERETEK UBT® Breath Test against established diagnostic methods, not on how human readers improve with or without AI assistance. The device is a diagnostic test kit, not a software AI assistant for human interpretation.
5. If a Standalone Study Was Done
Yes, a standalone study was done. The entire clinical testing section describes the performance of the MERETEK UBT® Breath Test itself (the "algorithm only") in detecting H. pylori by measuring 13CO2/12CO2 ratios. The results (sensitivity, specificity) presented in the tables are precisely the standalone performance characteristics of the diagnostic test.
6. The Type of Ground Truth Used
The ground truth used was a combination of established clinical and laboratory diagnostic methods:
- For Initial Diagnosis: CLOtest®, Histopathology, and Microbiological Culture. The "combined endoscopic methods" standard for initial diagnosis included CLOtest®, histology, and culture.
- For Post-Treatment Monitoring: Histopathology and Microbiological Culture. The "combined endoscopic methods" standard for post-treatment monitoring included histology and culture.
These methods represent a form of expert consensus if multiple methods were combined to form a reference standard, or a pathology-like reference (histology and culture are pathology methods). It is not directly called "outcomes data," though the goal is to ultimately inform patient outcomes.
7. The Sample Size for the Training Set
The document does not specify a training set sample size. This implies that the device in question (MERETEK UBT® Breath Test) is a diagnostic kit with a fixed methodology (measuring 13CO2/12CO2 ratio) and does not involve AI or machine learning models that typically require a separate training set. The study described is for validation and performance assessment, not for training a model.
8. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for an AI/ML model, the establishment of ground truth for a training set is not applicable to this document. The ground truth as described for the test set was established by concurrent clinical and laboratory diagnostic methods (CLOtest, histology, culture).
§ 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).