510(k) · Cleared
ClearedElecsys Probnp II Calcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Feb 27, 2008 as substantially equivalent to K020883 (Roche Diagnostics Corp., 2002) after a 36-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Feb 27, 2008
- Review
- 36 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001015 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 1 generation backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- This deviceK080147 Elecsys Probnp II CalcheckRoche Diagnostics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK092169 Elecsys Probnp II Calcheck 5Roche Diagnostics · 2009
Most influential descendants
Showing 1 of 1 · See all- K092169Elecsys Probnp II Calcheck 5Roche Diagnostics · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −1 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K080147 | Elecsys Probnp II Calcheck | Roche Diagnostics Corp. | 2008 | — |
| +1 | K092169 | Elecsys Probnp II Calcheck 5 | Roche Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 JJX? 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 |
|---|---|---|---|
| * | K020883 | Elecsys Probnp CalcheckSummary page 1…r products device in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys ProBNP CalCheck (K020883). Device The Elecsys proBNP II CalCheck is a lyophilized product consisting of Description NT-proBNP (1-76) amid… | 2002 |
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 |
|---|---|---|---|
| K092169 | Elecsys Probnp II Calcheck 5 | 2009 | 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092169 (Roche Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020883.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The electrochemiluminescence inmmnoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080147: Elecsys Probnp II Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080147
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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