510(k) · Cleared
ClearedStratus CS Trop Calpak
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 Apr 16, 1998 after a 21-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 16, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK981100 Stratus CS Trop CalpakDade Behring, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK983722 Stratus CS Troponin I CalibratorDade Behring, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK012233 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 3 of 3 · See all- K983722Stratus CS Troponin I CalibratorDade Behring, Inc. · 1998 · cites it directly2descendants
- K012233Stratus CS Troponin I CalibratorDade Behring, Inc. · 2001 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K981100 | Stratus CS Trop Calpak | Dade Behring, Inc. | 1998 | — |
| +1 | K983722 | Stratus CS Troponin I Calibrator | Dade Behring, Inc. | 1998 | — |
| +2 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Stratus® troponin I calibrator Named without a submission number |
What descends from it? (3)
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?
- Of its descendants, K983722 (Dade Behring, Inc., 1998) has gone furthest, with 2 descendants of its own.
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 TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric 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/K981100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981100: Stratus CS Trop Calpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981100
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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