# K984067: Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 13, 1999 after 58 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981099 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981099: Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- K051650: Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak. (2005), 0 descendants of its own

## Recalls of this device
- Jun 22, 2016 · Class II · Z-2525-2016: 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 contr
- Dec 7, 2009 · Not classified · Z-0343-2011: 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: 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 fals

## Indications for use
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.

Source page: https://510kreport.com/device/K984067
Methodology: https://510kreport.com/methodology