(167 days)
The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.
Visually read, single use test cassette.
The provided 510(k) summary for the AccuStat H. pylori One Step Test does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria. It primarily focuses on establishing substantial equivalence to predicate devices.
However, based on the information provided, here's what can be extracted and inferred regarding performance and study details:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria (e.g., minimum sensitivity, specificity) are stated in the document. The filing focuses on demonstrating substantial equivalence to predicate devices with similar methodology and intended use. Therefore, a table of acceptance criteria and reported performance cannot be directly constructed from this document.
The document mentions that the predicate devices, Smith Kline FlexSure HP and QuickVue One-Step H. Pylori tests, have been determined eligible for a CLIA waiver due to their simple methodologies. This implies that the new device, by being substantially equivalent, would also aim for similar ease of use and performance suitable for such waiver.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on the sample size used for the test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for performance claims.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The 510(k) summary does not specify the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set. Given the nature of a rapid diagnostic test for antibodies, the result is typically a direct visual interpretation by the user/technician, rather than a process requiring expert adjudication in a clinical trial context as might be seen for imaging devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This is expected as the device is a manual, visually interpreted immunoassay, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The 510(k) summary does not refer to a standalone algorithm performance study. The device is a "visually read, single use test cassette," implying human interpretation is an integral part of its use, and there is no standalone algorithm.
7. The Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used for any performance evaluation. For a serological test detecting antibodies to H. pylori, ground truth would typically be established by:
- Culture: Gold standard for direct detection of H. pylori.
- Histology: Biopsy examination for H. pylori presence.
- Urea Breath Test (UBT) or Stool Antigen Test (SAT): Non-invasive tests for active infection.
- Expert Consensus on a combination of clinical symptoms and other diagnostic tests: Especially for establishing H. pylori infection status in symptomatic patients.
8. The Sample Size for the Training Set
The 510(k) summary does not provide any information about a training set or its sample size. This type of information is typically relevant for machine learning or AI-driven devices, which is not the case here.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned or implied, the method for establishing its ground truth is also not provided.
§ 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).