510(k) · Cleared
ClearedIds-Isys Intact PTH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Feb 3, 2012 after a 448-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 3, 2012
- Review
- 448 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK103325 Ids-Isys Intact PTHImmunodiagnostic Systems, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK161158 IDS-iSYS Intact PTHNImmunodiagnostic Systems, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103325 | Ids-Isys Intact PTH | Immunodiagnostic Systems, Ltd. | 2012 | — |
| +1 | K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEW? 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 CEW device
- #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161158 | IDS-iSYS Intact PTHN | 2017 | 0 |
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?
- Of its descendants, K161158 (Immunodiagnostic Systems, Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CEW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEW
160in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEW
37in 2025
MAUDE reports naming product code CEW, 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 | 4 | 160 | 1 | 0 |
| 2008 | 0 | — | 1 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 3 | 23 |
| 2011 | 0 | — | 0 | 97 |
| 2012 | 1 | — | 0 | 124 |
| 2013 | 2 | — | 1 | 172 |
| 2014 | 1 | — | 0 | 167 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 0 | — | 2 | 98 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 65 |
| 2019 | 1 | — | 0 | 77 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 2 | 188 |
| 2023 | 1 | — | 0 | 82 |
| 2024 | 2 | — | 2 | 67 |
| 2025 | 0 | — | 1 | 37 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemnia and hypocalcemia resulting from disorders of calcium metabolism. The kit is for in vitro diagnostic use only. The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the…
Read the full statement (118 words)
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemnia and hypocalcemia resulting from disorders of calcium metabolism.
The kit is for in vitro diagnostic use only.
The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay.
The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay.
The IDS-iSYS iPTIH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103325: Ids-Isys Intact PTH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103325
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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