Search Results
Found 1 results
510(k) Data Aggregation
(57 days)
The intended use of the Gastrin EIA is for quantitative measurement of Gastrin in human serum. Gastrin is a polypeptide hormone produced and secreted by the G cells of the gastric antral mucosa. It occurs in the circulation in several different forms, among those Gastrin-17 and Gastrin-34, sulphated and nonsulphated. The determination of serum gastrin can be used as an aid in the diagnosis of Zollinger-Ellison Syndrome, gastric cancers, achlorhydia ( with or without pernicious anaemia), G-cell hyperplasia and duodenal ulcer. In all of these clinical conditions the serum gastrin concentration is elevated. Normal fasting serum gastrin concentrations are below 100 pg/ml, while fasting serum levels in the above conditions are significantly higher. Measurement of serum gastrin may also be used to monitor patients with previous gastric surgery. Treatment with histamine H2 receptor antagonists and with antisecretory drugs may cause a rise in the serum gastrin concentration. Quantification of serum gastrin can then be used to monitor treatment with these drugs.
Gastrin EIA is an in vitro enzyme immunoassay for the quantitative measurement of gastrin in human serum. Gastrin in serum is assayed by a competition reaction using an antibody raised against a gastrin immunogen. Gastrin in standards and samples compete with immobolised Gastrin in binding the antigastrin antibody. The extent of antibody binding to the solid phase is inversely related to the concentration of Gastrin in the standard or patient sample.
The provided text describes a 510(k) summary for the Gastrin EIA, an in vitro enzyme immunoassay. The acceptance criteria and the study proving the device meets these criteria are related to its substantial equivalence to a predicate device, the Gastrin (I125) Radioimmunoassay Kit (K821175).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device. This is primarily assessed through a comparison of technological characteristics and clinical performance.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Gastrin EIA) |
|---|---|---|
| Technological Equivalence | Quantify gastrin in a patient's serum sample by means of a competition reaction. | The Gastrin EIA is designed to quantify gastrin in a patient's serum sample by means of a competition reaction. |
| Use a multi-specific antiserum generated against a gastrin immunogen. | The Gastrin EIA uses a multi-specific antiserum generated against a gastrin immunogen. | |
| Detection method (differences are acknowledged but must not negatively impact performance). | The EIA uses an antibody-enzyme conjugate and chromogenic substrate (non-hazardous, non-carcinogenic) whereas the Predicate RIA uses a radioactive tracer. | |
| Standard curve range. | The EIA expands on the RIA standard curve, facilitating easier measurement of very high patient samples. | |
| Use of human components in standards. | Unlike the RIA, the EIA does not use any extracted human components in its standards. | |
| Clinical Performance | No statistical difference in gastrin measurements when compared to the predicate device. This implies high correlation and agreement between results obtained from both methods for patient samples. (Implicitly, accuracy and precision). | Patient samples were analyzed by both EIA and RIA, and results were subjected to linear regression analysis. The study reported "no statistical difference between the two tests," implying the Gastrin EIA's measurements of gastrin in human serum are comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly states: "Patient samples were analysed by both EIA and RIA..."
- Sample Size: The specific number of patient samples is not provided in the given text.
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "Patient samples," which generally implies human biological samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study described is a comparison study between two diagnostic kits, not a study to establish a new ground truth based on expert consensus for the presence of a disease. Instead, the "ground truth" for the performance comparison in this context is the measurement obtained from the predicate device (Gastrin (I125) Radioimmunoassay Kit K821175), which is assumed to be an established and accepted method for gastrin quantification.
Therefore:
- Number of experts: Not applicable in the context of establishing ground truth for the test set by expert review.
- Qualifications of experts: Not applicable. The "ground truth" is the predicate device's measurement.
4. Adjudication Method for the Test Set
The study involved analyzing patient samples with both devices and performing a linear regression analysis. This indicates a direct comparison of quantitative measurements.
- Adjudication method: None in the sense of a panel of experts resolving discrepancies. The comparison relies on statistical analysis of the quantitative results from the two assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No. This device is an in vitro diagnostic (IVD) kit for quantitative measurement and does not involve human readers interpreting images or results in a way that an MRMC study would be appropriate. The "readers" are the assays themselves, which provide quantitative outputs.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in effect. The Gastrin EIA is a laboratory assay kit designed to provide a quantitative measurement of gastrin. Its performance is evaluated intrinsically through its ability to measure gastrin comparable to a predicate device. It operates as an "algorithm only" (or assay-only) system without a human interpretation loop forming part of its core performance evaluation in the way a diagnostic imaging AI might. The "performance" being evaluated is the kit's ability to produce a result, which is then compared to another kit's result.
7. Type of Ground Truth Used
The "ground truth" for the comparison study was the measurements obtained from the Gastrin (I125) Radioimmunoassay Kit (K821175). This predicate device served as the reference standard against which the new Gastrin EIA was evaluated.
- Type of ground truth: Reference standard/Predicate device measurements.
8. Sample Size for the Training Set
The provided text does not mention a training set or details about how the Gastrin EIA itself was developed or "trained." This is typical for an immunoassay kit where the development involves optimizing reagents, antibodies, and protocols rather than a machine learning training paradigm.
- Sample size for training set: Not provided / Not applicable in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or applicable in the context of an immunoassay kit in the way it would be for a machine learning algorithm, this question is not applicable. The "ground truth" for developing such a kit would implicitly involve established biochemical and immunological principles to ensure the assay accurately binds to and detects gastrin.
Ask a specific question about this device
Page 1 of 1