510(k) · Cleared
ClearedRoche Elecsys 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 Jul 13, 2007 as substantially equivalent to K992680 (Roche Diagnostics Corp., 1999) after a 121-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 121 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954418 (1995). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK070709 Roche Elecsys PTH Test SystemRoche Diagnostics Corp. · 2007
- Descendant · cites it directly · 0 of its ownK231927 Elecsys PTH , Elecsys PTH STATRoche Diagnostics · 2024
- Descendant · cites it directly · 0 of its ownK221197 VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −1 | K992680 | Elecsys Parathyroid Hormone Test System | Roche Diagnostics Corp. | 1999 | 1 |
| 0 (this device) | K070709 | Roche Elecsys PTH Test System | Roche Diagnostics Corp. | 2007 | — |
| +1 | K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 2024 | — |
| +1 | K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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…leesys PTH and Elecsys PTH STAT Immunoassays (expanded intended use) are equivalent to the Elecsys Parathyroid Hormone Test System (K992680). Device The following table compares the Elecsys PTH and Elecsys PTH STAT Test Comparison Systems and the… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K231927 (Roche Diagnostics, 2024) has gone furthest, with 0 descendants of its own.
- 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?
The Elecsys PTH: Immunoassay for the in vitro quantitative detennination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH assay can be used intraoperatively.
The Elecsys PTH STAT: Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH STAT assay can be used intraoperatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070709: Roche 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/K070709
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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