510(k) · Cleared
ClearedElecsys Callcheck Digoxin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DMP Digoxin Control Serum, Ria
Cleared on Nov 4, 1997 as substantially equivalent to K963147 (Boehringer Mannheim Corp., 1996) after a 15-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- DMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924862 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 1 generation backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- This deviceK973973 Elecsys Callcheck DigoxinBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 2 of its ownK102044 Elecsys Digoxin Calcheck 5Roche Diagnostics · 2010
- Descendant · 2 generations on · 0 of its ownK140267 Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK112113 Elecsys Myoglobin Calcheck 5Roche Diagnostics · 2011
Most influential descendants
Showing 3 of 3 · See all- K102044Elecsys Digoxin Calcheck 5Roche Diagnostics · 2010 · cites it directly2descendants
- K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
- K112113Elecsys Myoglobin Calcheck 5Roche Diagnostics · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −1 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K973973 | Elecsys Callcheck Digoxin | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K102044 | Elecsys Digoxin Calcheck 5 | Roche Diagnostics | 2010 | — |
| +2 | K140267 | Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K112113 | Elecsys Myoglobin Calcheck 5 | Roche Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 DMP? 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 |
|---|---|---|---|
| * | K963147 | Elecsys Calcheck TSHSummary page 1…: Single (specified) analyte controls (assayed + unassayed) The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102044 | Elecsys Digoxin Calcheck 5 | 2010 | 2 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102044 (Roche Diagnostics, 2010) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K963147.
How does its category compare?
All DMP devicesDMP Digoxin Control Serum, Ria: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DMP
FDA has decided no DMP device since 2007.
Median 510(k) review, days · DMP
Too few DMP 510(k)s in any year since 2007 to give a median.
Recalls per year · DMP
No recall names DMP since 2007.
Adverse event reports per year · DMP
No MAUDE report names DMP since 2007.
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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.
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/K973973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973973: Elecsys Callcheck Digoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973973
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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