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510(k) Data Aggregation
(308 days)
The Helicobacter pylori (H. pylori) ELISA IgA test kit is intended for the qualitative detection of IgA antibodies to H. pylori in human serum in the adult population. This test is intended as a second test to aid in the diagnosis of H. pylori in patients with gastrointestinal symptoms, in conjunction with clinical findings. It should be performed and interpreted with another assay for detection of IgG antibodies to H. pylori.
The assay requires a total of 90 minutes incubation time. The test uses purified antigen coated on microtiter wells. Serum is added to each well and incubated for 30 minutes at 37°C. If H. pylori IgA antibodies are present they will bind to the antigen in the well. Unbound serum is removed by washing the wells three times. An HRP-conjugated anti-human IgA is then added to each well and incubated for 30 minutes at 37°C. If H. pylori antibody is present, it will bind to the antibody attached to the antigen on the wells are again washed three times to remove any unbound conjugate. A TMB substrate is added to each well and incubated for 30 minutes at 37°C. If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, Stop Solution and the color intensity is measured the reaction is stopped with a spectrophotometrically.
The document describes the Gold Standard Diagnostics Helicobacter pylori IgA ELISA Test Kit and its performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" through a formal table. However, the study focuses on demonstrating substantial equivalence to a predicate device, and the key performance metrics reported are Percent Positive Agreement, Percent Negative Agreement, and Overall Agreement with the predicate device (Micro Detect Inc. Pylori Detect IgA).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Gold Standard Diagnostics H. pylori ELISA IgA) |
|---|---|---|
| Percent Positive Agreement | Demonstrate substantial agreement with the predicate device. Specific threshold not explicitly stated but generally expected to be high for equivalence. | 94.5% (C.I. 76.0% - 100%) |
| Percent Negative Agreement | Demonstrate substantial agreement with the predicate device. Specific threshold not explicitly stated. | 93.8% (C.I. 88.8% - 99.5%) |
| Overall Agreement | Demonstrate substantial agreement with the predicate device. Specific threshold not explicitly stated. | 94.0% (C.I. 85.9% - 100%) |
| Intra-Assay CV | Acceptable precision for diagnostic assays (e.g., typically |
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