(216 days)
The Helicobacter pyloxi IgG ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human IgG class antibodies to Helicobacter pylori in serum and in EDTA or heparin-treated plasma. The test is intended to aid in the diagnosis of Helicobacter pylori infection in adult patients with clinical symptoms of gastritis. FOR INVITRO DIAGNOSTIC USE.
The Helicobacter pylori IgG ELISA is an immunoassay to detect IgG antibodies to Helicobacter pylori. The assay requires a total of 90-minutes incubation. The test uses partially purified Helicobacter pylori bacterial antigen adsorbed to a solid phase microassay well. Prediluted test serum or plasma is added to each well and incubated for 30 minutes at 37℃. If Helicobacter pylori-specific IgG antibodies are present, they will bind to the antigen in the well. After the incubation, the wells are washed three times to remove any unbound serum or plasma. An HRP-conjugated monoclonal anti-human IgG is added to each well, and the test is incubated for 30 minutes at 37℃. If Helicobacter pylori antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are washed again to remove any unbound conjugate. A TMB-substrate is added to each well and incubated for 30 minutes at room temperature (20-25°C). If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically. The Helicobacter pylori IgG ELISA is highly sensitive for the detection of IgG antibodies to Helicobacter pvlori in serum or plasma samples.
Here's a breakdown of the acceptance criteria and study details for the Biohit Helicobacter pylori IgG ELISA, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of target percentages for sensitivity, specificity, or agreement. Instead, it reports the device's performance when compared to two different reference methods: histology (considered the "gold standard") and a legally marketed predicate ELISA. The conclusion for substantial equivalence is based on these reported performance metrics aligning with clinical expectations for such a device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (vs. Histology) | Reported Device Performance (vs. Predicate ELISA) |
|---|---|---|---|
| Sensitivity | Clinically acceptable | 80.9% | 88.6% |
| Specificity | Clinically acceptable | 75.8% | 100% |
| Predictive Positive Value (PPV) | Clinically acceptable | 64.6% | 100% |
| Predictive Negative Value (PNV) | Clinically acceptable | 87.9% | 96.2% |
| Agreement | Clinically acceptable | 77.6% | 97.0% |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size of the test set or the provenance of the data (country of origin, retrospective/prospective). It simply refers to "clinical evaluations" and comparison studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "Culture of the organism and/or histologic staining from a biopsy sample obtained at endoscopy is considered by the FDA to be the current 'Gold Standard' for detection of Helicobacter pylori". This implies a reliance on standard laboratory procedures and interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set. The ground truth was established by "Gold Standard" methods (histology) and comparison to a commercial ELISA.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was 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 done. This device is an immunoassay (ELISA) for detecting antibodies, not an imaging or diagnostic algorithm requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire study reported describes the standalone performance of the Biohit Helicobacter pylori IgG ELISA kit. This device is an in vitro diagnostic test, meaning its output is a direct result from the assay and does not involve a human-in-the-loop interpretation for its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth used was histology of biopsy samples, which is considered the "Gold Standard" by the FDA for the detection of Helicobacter pylori. Bacterial culture of biopsy samples is also mentioned as a "Gold Standard" method. The study also uses a legally marketed commercial enzyme immunoassay (IMMULITE® Helicobacter pylori IgG) as a comparative reference.
8. The sample size for the training set
The document does not provide information about a separate training set or its sample size. This is typical for a diagnostic kit submission, where development and internal validation (which might involve a "training" phase) are distinct from the clinical performance study reported for regulatory submission.
9. How the ground truth for the training set was established
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. The ground truth methods for the performance evaluation set are as described in point 7.
§ 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).