510(k) · Cleared
ClearedGastrin Eia Model 06B-555017
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosyn, Ltd. · CGC Radioimmunoassay, Gastrin
Cleared on May 30, 1996 as substantially equivalent to K821175 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1982) after a 57-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- May 30, 1996
- Review
- 57 days
- Class
- Class I
- Product code
- CGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821175 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK821175 Gastrin Radioimmunoassay Kit (125-I)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- This deviceK961276 Gastrin Eia Model 06B-555017Biosyn, Ltd. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821175 | Gastrin Radioimmunoassay Kit (125-I) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| 0 (this device) | K961276 | Gastrin Eia Model 06B-555017 | Biosyn, Ltd. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K821175 | Gastrin Radioimmunoassay Kit (125-I)Summary page 2…munoassay Kit Trade or proprietary name: Gastrin EIA A% (1271 Device to which Substantial Equivalence is claimed: Gastrin (I '**) Radioimmunoassay Kit. K821175 Description of Gastrin EIA: Gastrin EIA is an in vitro enzyme immunoassay for the quantitative measurement of gastrin in human… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CGC devicesCGC Radioimmunoassay, Gastrin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGC
FDA has decided no CGC device since 2007.
Median 510(k) review, days · CGC
Too few CGC 510(k)s in any year since 2007 to give a median.
Recalls per year · CGC
No recall names CGC since 2007.
Adverse event reports per year · CGC
1in 2025
MAUDE reports naming product code CGC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 non-sulphated. The determination of serum gastrin can be used as an aid in the diagnosis of Zollinger-Ellison Syndrome, gastric cancers, achlorhydia (…
Read the full statement (161 words)
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 non-sulphated. 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 H, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961276 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961276: Gastrin Eia Model 06B-555017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961276
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026