# K051650: Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak.

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 8, 2005 after 79 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981100 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984067: Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak, Dade Behring, Inc. (1999) Summary page 1.
- K981099: Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K981097: Stratus CS CKMB Calpak, Dade Behring, Inc. (1998) Summary page 1.
- K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni, Dade Behring, Inc. (2003) Summary page 1.
- K984093: Stratus (R) CS Cardiac Troponin I (Trop) Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K981098: Stratus CS Cardiac Troponin I Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K012233: Stratus CS Troponin I Calibrator, Dade Behring, Inc. (2001) Summary page 1.
- K983722: Stratus CS Troponin I Calibrator, Dade Behring, Inc. (1998) Summary page 1.
- K981100: Stratus CS Trop Calpak, Dade Behring, Inc. (1998) Summary page 6.
- K981102: Stratus CS Myoglobin (Myo) Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K984065: Stratus (R) CS Myoglobin (Myo) Testpak, Dade Behring, Inc. (1998) Summary page 1.
- K981101: Stratus CS Myo Calpak, Dade Behring, Inc. (1998) Summary page 1.

## Recalls of this device
- Mar 31, 2025 · Class II · Z-1673-2025: 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 increas
- May 29, 2019 · Class II · Z-2135-2019: 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: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Nov 11, 2015 · Class II · Z-0612-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Nov 11, 2015 · Class II · Z-0618-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Nov 11, 2015 · Class II · Z-0609-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Nov 11, 2015 · Class II · Z-0619-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Dec 23, 2010 · Not classified · Z-1732-2011: Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.
- Apr 13, 2010 · Not classified · Z-2400-2010: False elevated Stratus CS CTNI results
- Jun 23, 2008 · Not classified · Z-0668-2009: Incorrect result: Potential for false elevation of CTnI results
- Apr 28, 2008 · Not classified · Z-1555-2009: 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 p

## Indications for use
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.

Source page: https://510kreport.com/device/K051650
Methodology: https://510kreport.com/methodology