510(k) · Cleared
ClearedStratus CS Troponin I Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIT Calibrator, Secondary
Cleared on Sep 11, 2001 as substantially equivalent to K983722 (Dade Behring, Inc., 1998) after a 57-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Sep 11, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981100 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981100 Stratus CS Trop CalpakDade Behring, Inc. · 1998
- 1 generation backK983722 Stratus CS Troponin I CalibratorDade Behring, Inc. · 1998
- This deviceK012233 Stratus CS Troponin I CalibratorDade Behring, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK051650 Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test…Dade Behring, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…Dade Behring, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981100 | Stratus CS Trop Calpak | Dade Behring, Inc. | 1998 | — |
| −1 | K983722 | Stratus CS Troponin I Calibrator | Dade Behring, Inc. | 1998 | — |
| 0 (this device) | K012233 | Stratus CS Troponin I Calibrator | Dade Behring, Inc. | 2001 | — |
| +1 | K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus… | Dade Behring, Inc. | 2005 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 JIT? 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 |
|---|---|---|---|
| * | K983722 | Stratus CS Troponin I CalibratorSummary page 1…uly 12, 2001 Device Name: Stratus® CS Troponin I Calibrator (cTnl Cal Pak) FDA Classification Name: Calibrator, secondary Predicate Device: Stratus® CS TROP CalPak (K983722) Device Description: The Stratus® CS cTnl CalPak is a plastic cartridge, which contains buffered bovine protein with native hum… | 1998 |
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 |
|---|---|---|---|
| K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute… | 2005 | 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 3 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051650 (Dade Behring, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983722.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Cardiac Troponin I Calibrator (¢Tnl CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin [ method on the Stratus® CS analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
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/K012233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012233: Stratus CS Troponin I Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012233
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026