(57 days)
No
The description details a standard enzyme immunoassay (EIA) for measuring gastrin levels. There is no mention of AI, ML, or any computational analysis beyond standard quantitative measurement and statistical comparison to a predicate device.
No
The device is an in vitro diagnostic (IVD) immunoassay used to measure gastrin levels for diagnostic purposes, not to treat or directly manage a patient's condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "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."
No
The device description clearly states it is an "in vitro enzyme immunoassay," which is a laboratory test involving physical reagents and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for quantitative measurement of Gastrin in human serum." This indicates the device is used to analyze a biological sample (human serum) outside of the body.
- Device Description: The description states "Gastrin EIA is an in vitro enzyme immunoassay for the quantitative measurement of gastrin in human serum." The term "in vitro" directly means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Clinical Use: The intended use describes how the results of the test are used as an "aid in the diagnosis" of various clinical conditions. This diagnostic purpose is a core function of IVDs.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K821175 Gastrin (1 125) Radioimmunoassay Kit) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Patient samples were analysed by both EIA and RIA and results subjected to a linear regression analysis. Results obtained showed that their was no statistical difference between the two tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1325 Gastrin test system.
(a)
Identification. A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
2. 510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '9', '6', '1', '2', '7', and '6'. The characters are written in a simple, slightly irregular style, giving them a casual appearance.
MAY 3 0 1996
510(k) SUMMARY
[ as required by Section 807.92 (c)]
| Submitter's Name: | Biosyn Ltd |
|---|---|
| Address: | 10 Malone Road |
| Belfast | |
| BT9 5BN | |
| N. Ireland. | |
| Phone: | 00 44 1232 438442 |
| Fax: | 00 44 1232 663015 |
| Contact Person: | Jennifer McKay |
| Title: | Technical Manager |
| Date: | 29th March 1996. |
| PRODUCT INFORMATION | |
| Common/usual or classification name: | Gastrin Enzyme Immunoassay Kit |
| Trade or proprietary name: | Gastrin EIA |
1
Device to which Substantial Equivalence is claimed:
Gastrin (1 125) Radioimmunoassay Kit. K821175
Description of Gastrin EIA:
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.
Intended Use:
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.
Comparison of Technological Characteristics of EIA and RIA:
Both are designed to quantify gastrin in a patient's serum sample by means of a competition reaction. Both use a multi-specific antiserum generated against a gastrin immunogen. The RIA utilizes a radioactive tracer as its means of detection while the EIA uses a an antibody-enzyme conjugate and chromogenic substrate both of which are non-hazardous and non-carcinogenic. The EIA expands on the RIA standard curve facilitating easier measurement of very high patient samples. Unlike the RIA, the EIA does not use any extracted human components in its standards.
2
Assessment of Clinical Performance Data:
Patient samples were analysed by both EIA and RIA and results subjected to a linear regression analysis. Results obtained showed that their was no statistical difference between the two tests.
Conclusions:
Comparison of the technological characteristics of the EIA and RIA in conjunction with the Clinical performance data show that the Gastrin EIA is substantially equivalent to the RIA K821175.