510(k) · Cleared
Recalled · Class II · 2016Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak
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 Jan 13, 1999 as substantially equivalent to K981099 (Dade Behring, Inc., 1998) after a 58-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jan 13, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- JHX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981099 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981099 Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB TestpakDade Behring, Inc. · 1998 · Recalled
- This deviceK984067 Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test…Dade Behring, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| −1 | K981099 | Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak | Dade Behring, Inc. | 1998 | 1 |
| 0 (this device) | K984067 | Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak | Dade Behring, Inc. | 1999 | — |
| +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 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 |
|---|---|---|---|
| * | K981099 | Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB TestpakSummary page 1…us® CS CKMB TestPak Classification Name: Fluorometer, for Clinical Use Fluorometric Method, CPK or iscenzymes Predicate Device: Stratus® CS STAT Fluorometric Analyzer (K981099) : Stratus® CS CKMB TestPak (K981099) Device Description: The Stratus® CS STAT Fluorometric Analyzer is a benchtop analyzer capa… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2016 | Class II | Z-2525-2016 | Software design | Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due… |
| Dec 7, 2009 | Not classified | Z-0343-2011 | Process control | Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation. |
| Apr 3, 2006 | Not classified | Z-0875-06 | Other | Foil sealing of the TestPak 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?
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?
The Stratus® CS STAT Fluorometric Analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.
Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
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/K984067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984067: Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984067
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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