510(k) · Cleared
Recalled · Class II · 2025Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care 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 Sep 8, 2005 as substantially equivalent to K984067 (Dade Behring, Inc., 1999) and 11 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1998. It has been recalled 11 times.
- Decided
- Sep 8, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- JHX
- Recalls
- 11
- Predicates
- 12
Its longest line of descent runs back 3 generations to K981100 (1998). 12 ancestors in all, the oldest K981101 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK981100 Stratus CS Trop CalpakDade Behring, Inc. · 1998
- 2 generations backK983722 Stratus CS Troponin I CalibratorDade Behring, Inc. · 1998
- 1 generation backK012233 Stratus CS Troponin I CalibratorDade Behring, Inc. · 2001
- This deviceK051650 Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test…Dade Behring, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981100 | Stratus CS Trop Calpak | Dade Behring, Inc. | 1998 | — |
| −2 | K983722 | Stratus CS Troponin I Calibrator | Dade Behring, Inc. | 1998 | — |
| −1 | K012233 | Stratus CS Troponin I Calibrator | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus… | Dade Behring, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2003 | 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? (12)
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 |
|---|---|---|---|
| * | K984067 | Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test PakSummary page 1…ices or Multiple Indications in a Single Submission” - 11/26/2003 Predicate Device(s): Dade Behring Stratus® STAT Fluorometric Analyzer CKMB TestPak including DilPak (K984067/K981099) and Stratus® CS CKMB CalPak (K981097) (Note: This submission included the Stratus® CS STAT Fluorometric Analyzer in add… | 1999 |
| * | K981099 | Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB TestpakSummary page 1…Multiple Indications in a Single Submission” - 11/26/2003 Predicate Device(s): Dade Behring Stratus® STAT Fluorometric Analyzer CKMB TestPak including DilPak (K984067/K981099) and Stratus® CS CKMB CalPak (K981097) (Note: This submission included the Stratus® CS STAT Fluorometric Analyzer in addition to… | 1998 |
| * | K981097 | Stratus CS CKMB CalpakSummary page 1…ission” - 11/26/2003 Predicate Device(s): Dade Behring Stratus® STAT Fluorometric Analyzer CKMB TestPak including DilPak (K984067/K981099) and Stratus® CS CKMB CalPak (K981097) (Note: This submission included the Stratus® CS STAT Fluorometric Analyzer in addition to the CKMB TestPak and DilPak) Dade Be… | 1998 |
| * | K033487 | Stratus CS Acute Care Troponin I Testpak, Model CctniSummary page 1…the Stratus® CS STAT Fluorometric Analyzer in addition to the CKMB TestPak and DilPak) Dade Behring Stratus® CS Acute Care™ Troponin I (¢TnI) TestPak including DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO T… | 2003 |
| * | K984093 | Stratus (R) CS Cardiac Troponin I (Trop) TestpakSummary page 1…atus® CS STAT Fluorometric Analyzer in addition to the CKMB TestPak and DilPak) Dade Behring Stratus® CS Acute Care™ Troponin I (¢TnI) TestPak including DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak i… | 1998 |
| * | K981098 | Stratus CS Cardiac Troponin I TestpakSummary page 1…STAT Fluorometric Analyzer in addition to the CKMB TestPak and DilPak) Dade Behring Stratus® CS Acute Care™ Troponin I (¢TnI) TestPak including DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including… | 1998 |
| * | K012233 | Stratus CS Troponin I CalibratorSummary page 1…n to the CKMB TestPak and DilPak) Dade Behring Stratus® CS Acute Care™ Troponin I (¢TnI) TestPak including DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including DilPak (K981102/K984065) and Stratus®… | 2001 |
| * | K983722 | Stratus CS Troponin I CalibratorSummary page 1…CKMB TestPak and DilPak) Dade Behring Stratus® CS Acute Care™ Troponin I (¢TnI) TestPak including DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including DilPak (K981102/K984065) and Stratus® CS MYO… | 1998 |
| * | K981100 | Stratus CS Trop CalpakSummary page 6…CalPak) is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus CS Acute Care Tm Troponin I CalPak (K012233/K983722/K981100). Both calibrators are intended to be used to calibrate the Troponin I (cTnI) assay on the Stratus® CS analyzer. There are no fo… | 1998 |
| * | K981102 | Stratus CS Myoglobin (Myo) TestpakSummary page 1…DilPak (K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including DilPak (K981102/K984065) and Stratus® CS MYO CalPak (K981101) 10 Device Description(s): CKMB Method The Stratus® CS Acute CareT… | 1998 |
| * | K984065 | Stratus (R) CS Myoglobin (Myo) TestpakSummary page 1…K033487/K984093/K981098) and Stratus® CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including DilPak (K981102/K984065) and Stratus® CS MYO CalPak (K981101) 10 Device Description(s): CKMB Method The Stratus® CS Acute CareT M CKMB… | 1998 |
| * | K981101 | Stratus CS Myo CalpakSummary page 1…CS cTnl CalPak (K012233/K983722/K012233) Dade Behring Stratus® CS STAT Fluorometric Analyzer MYO TestPak including DilPak (K981102/K984065) and Stratus® CS MYO CalPak (K981101) 10 Device Description(s): CKMB Method The Stratus® CS Acute CareT M CKMB method is a two-site sandwich assay b… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2025 | Class II | Z-1673-2025 | Under Investigation by firm | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable… |
| May 29, 2019 | Class II | Z-2135-2019 | Under Investigation by firm | Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. |
| Nov 11, 2015 | Class II | Z-0613-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Nov 11, 2015 | Class II | Z-0612-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Nov 11, 2015 | Class II | Z-0618-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Nov 11, 2015 | Class II | Z-0609-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Nov 11, 2015 | Class II | Z-0619-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Dec 23, 2010 | Not classified | Z-1732-2011 | Other | Low frequency of non-repeatable falsely elevated CTNI results without an associated error message. |
| Apr 13, 2010 | Not classified | Z-2400-2010 | Process control | False elevated Stratus CS CTNI results |
| Jun 23, 2008 | Not classified | Z-0668-2009 | Nonconforming Material/Component | Incorrect result: Potential for false elevation of CTnI results |
| Apr 28, 2008 | Not classified | Z-1555-2009 | Labeling False and Misleading | The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI).… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- 5 of the 12 ancestors have a recall of any class.
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 Acute CareTM CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E.C. No 2.7.3.2) in heparinized plasma. Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This method is for use by trained health care professionals in the clinical laboratory…
Read the full statement (430 words)
The Stratus® CS Acute CareTM CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E.C. No 2.7.3.2) in heparinized plasma. Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
The Stratus® CS Acute Care TM CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute CareTM CKMB method.
The Stratus® CS Acute CareTM CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute CareTM CKMB TestPak for the measurement of samples with elevated levels of CKMB.
The Stratus® CS Acute CareTrm Troponin I method (cTnl) is an in vitro diagnostic assay for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
The Stratus® CS Acute CareTm Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute CareTm Troponin I method.
The Stratus® CS Acute CareTm Troponin I Dilution Pak (cTnI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute CareTm cTnI TestPak for the measurement of samples with elevated levels of cardiac Troponin I.
The Stratus® CS Acute CareTm Myoglobin method (MYO) is an in vitro diagnostic assay for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin aid in the rapid diagnosis of renal or heart disease, e.g. myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
The Stratus® CS Acute CareTM Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute CareTm myoglobin method.
The Stratus® CS Acute CareTm Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute CareTm MYO TestPak for the measurement of samples with elevated Myoglobin levels.
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/K051650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051650: Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care 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/K051650
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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