(75 days)
The QuickVue One-Step H. pylori II Test is intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood as an aid in the diagnosis of H. pv/ori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use bv health care professionals.
The QuickVue One-Step H. pylori II Test, a lateral-flow immunoassay using patented technology, employs a monoclonal antibody and purified H. pylori antigen. Shortly after addition of the sample to the Test Cassette, a blue procedural Control Line will appear in the Result Window. If H. pylori-specific lqG is present in the sample, a faint-to-dark red Test Line will also appear in the Result Window. The result is read at 5 minutes. If no blue procedural Control Line develops, the result is considered invalid.
Here is the information about the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aimed to demonstrate "substantial equivalence" to existing methods, and an agreement exceeding 90% was considered acceptable for this purpose.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence | Agreement exceeding 90% in comparison to biopsy and a commercially available EIA |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Over 300 clinical specimens.
- Data Provenance: The specimens were obtained from symptomatic and asymptomatic patients undergoing endoscopic examination. The study was a "multi-center field study," implying data from multiple locations, but specific countries are not mentioned. It is a prospective study as it involved collecting clinical specimens and comparing the new device's performance to existing methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text does not specify the number of experts or their qualifications for establishing the ground truth (biopsy and EIA results) for the clinical specimens.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The comparison was made against "biopsy and to a commercially available EIA," suggesting that the results from these established methods served as the reference without a described adjudication process among multiple reviewers for the ground truth itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a rapid, qualitative immunoassay for detecting antibodies, not an AI-powered diagnostic tool requiring human readability or interpretation in the way an MRMC study would typically evaluate. Physician’s Office Laboratory (POL) studies were conducted to show that diverse office personnel could perform the test accurately and reproducibly, but this is different from an MRMC study evaluating human reader performance on diagnostic images with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an in-vitro diagnostic test kit. The "standalone" performance in this context refers to its intrinsic analytical performance. The study comparing the QuickVue test to biopsy and a commercial EIA constitutes the standalone performance of the device in its intended use, as it directly evaluates the device's accuracy in detecting IgG antibodies. There isn't an "algorithm only without human-in-the-loop" equivalent in this type of diagnostic device.
7. The Type of Ground Truth Used
The ground truth used for the clinical specimen comparison was a combination of:
- Biopsy: This refers to the histological examination of tissue samples, which is considered a gold standard for H. pylori detection.
- Commercially Available EIA: This is another established serological test method for detecting H. pylori antibodies.
8. The Sample Size for the Training Set
The text does not mention a separate training set or its sample size. This type of device (immunoassay) is typically developed and optimized through laboratory research, and then validated with clinical samples. The "over 300 clinical specimens" are described as being used for the comparative field study, which acts as the validation or test set.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated training set is not explicitly mentioned, the establishment of ground truth for such a set is also not described. The development of the QuickVue One-Step H. pylori II Test would have involved internal validation and optimization against known positive and negative controls in development, but these are not referred to as a "training set" in the context of this regulatory submission.
§ 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).