(413 days)
The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.
The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively.
When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.
Here's a breakdown of the acceptance criteria and study details for the RAPIRUN H. pylori Antibody Detection Kit, based on the provided text:
Acceptance Criteria and Device Performance
- Note: The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that were required for clearance. Instead, it presents the results of the clinical study, which are then used to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria would be for the device's performance to be comparable to, or "substantially equivalent" to, the predicate devices.
| Metric | Predicate Device 1 (HM-CAP™ EIA) Comparison | Predicate Device 2 (UBiT-IR300) Comparison |
|---|---|---|
| % Overall Agreement | 87.23% (95% CI: 81.97, 91.39) | 93.09% (95% CI: 88.51, 96.27) |
| % Positive Agreement | 84.71% (95% CI: 75.82, 91.30) | 86.46% (95% CI: 78.53, 92.40) |
| % Negative Agreement | 89.32% (95% CI: 81.96, 94.31) | 100.00% (95% CI: 96.17, 100.00) |
Study Information
1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: 188 evaluable subjects.
* Data Provenance: Prospective, multi-center study conducted at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The country of origin is not explicitly stated, but the sponsor is Japanese and the contact information includes a US contact, suggesting the study was likely conducted in the US (given the FDA submission context).
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* The study did not use human experts to establish "ground truth" for the test set in the traditional sense of diagnostic interpretation. Instead, it used predicate medical devices (HM-CAP™ H. pylori Enzyme Immunoassay Test and UBiT-IR300 Infrared Spectrophotometer) as the reference standards for comparison. Therefore, no information is provided about the number or qualifications of experts for ground truth establishment.
3. Adjudication Method for the Test Set:
* Not applicable. The "ground truth" was established by the results of predicate devices, not through expert consensus requiring adjudication.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
* No, an MRMC comparative effectiveness study was not done. This was a direct comparison of the new device to existing predicate devices, not a study evaluating human reader performance with and without AI assistance.
5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
* Yes, this was a standalone performance study. The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay with visual interpretation of test and control lines. Its performance was evaluated purely based on its own output compared to the predicate devices, without human-in-the-loop assistance in the sense of an algorithm supporting a human reader.
6. The Type of Ground Truth Used:
* The "ground truth" for evaluating the RAPIRUN Kit was established by predicate medical devices:
* HM-CAP™ H. pylori Enzyme Immunoassay Test (serum)
* UBiT-IR300 Infrared Spectrophotometer method (breath)
* These predicate devices themselves are considered established methods for diagnosing H. pylori infection.
7. Sample Size for the Training Set:
* The document does not mention a "training set" or "training data" for the device itself. Immunochromatographic assays like the RAPIRUN Kit are typically developed and optimized through laboratory studies and then directly validated in clinical performance studies. They are not machine learning algorithms that require a distinct training phase with annotated data in the same way.
8. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no mention of a distinct "training set" or "ground truth for the training set" in the context of this device's development as described.
§ 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).