510(k) · Cleared
Recalled · 2006Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on May 26, 1998 after a 61-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.
- Decided
- May 26, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- JHX
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK981099 Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB TestpakDade Behring, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK984067 Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test…Dade Behring, Inc. · 1999 · Recalled
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981099 | Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak | Dade Behring, Inc. | 1998 | — |
| +1 | K984067 | Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak | Dade Behring, Inc. | 1999 | 3 |
| +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 |
|---|---|---|
| 1999 | 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 JHX? 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 JHX device
- #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Dade Stratus® fluorometric analyzer Named without a submission number |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0881-06 | Other | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984067 (Dade Behring, Inc., 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JHX devicesJHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHX
Too few JHX 510(k)s in any year since 2007 to give a median.
Recalls per year · JHX
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHX
1in 2025
MAUDE reports naming product code JHX, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 6 |
| 2009 | 1 | — | 1 | 40 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 1 | — | 4 | 18 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 2 | 8 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.
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/K981099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981099: Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981099
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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