510(k) · Cleared
ClearedElecsys PTH Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Mar 20, 2007 as substantially equivalent to K992680 (Roche Diagnostics Corp., 1999) after a 39-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 20, 2007
- Review
- 39 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954418 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 1 generation backK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999 · Recalled
- This deviceK070391 Elecsys PTH Test SystemRoche Diagnostics Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
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 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? (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 |
|---|---|---|---|
| * | K992680 | Elecsys Parathyroid Hormone Test SystemSummary page 2…valence other devices legally marketed in the United States. The Elecsys PTH STAT Test System (modified) is equivalent to the Elecsys PTH System (K992680). Device The following table compares the Elecsys PTH STAT Test System (modified) Comparison and the predic… | 1999 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K992680.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Elecsys PTH Immunoassay (18 minute application) Elecsys PTH STAT Immunoassay (9 minute application) Inmunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PTH STAT CalSet Elecsys PTH CalSet STAT is used for…
Read the full statement (111 words)
Elecsys PTH Immunoassay (18 minute application)
Elecsys PTH STAT Immunoassay (9 minute application)
Inmunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PTH STAT CalSet
Elecsys PTH CalSet STAT is used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers.
Elecsys PTH CalSet
Elecsys PTH CalSet is used for calibrating the quantitative Elecsys PTH assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070391: Elecsys PTH Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070391
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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