510(k) · Cleared
Recalled · Class II · 2014Sangui Biotech, Inc. Calcitonin Elisa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sangui Biotech, Inc. · JKR Radioimmunoassay, Calcitonin
Cleared on Sep 3, 1998 after a 48-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Sep 3, 1998
- Review
- 48 days
- Class
- Class II
- Product code
- JKR
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JKR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JKR device
- #1 K252431 Elecsys Calcitoninscore 13.9 · 10 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay (Coated Bead Technology)… Named without a submission number | |
| * | — | Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2014 | Class II | Z-0467-2015 | Material/Component Contamination | A potential issue with false high values. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JKR devicesJKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKR
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JKR
Too few JKR 510(k)s in any year since 2007 to give a median.
Recalls per year · JKR
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKR
1in 2025
MAUDE reports naming product code JKR, 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 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of this product is the quantitative determination of Calcitonin in human serum. This immunocassay is based on the principles of the two site “sandwich” Enzyme-Linked ImmunoSorbent Assay (ELISA). Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
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/K982491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982491: Sangui Biotech, Inc. Calcitonin Elisa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982491
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026