# K981099: Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 26, 1998 after 61 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Dade Stratus® fluorometric analyzer: named in the summary without a submission number

## Most influential descendants
- K984067: Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak (1999), 1 descendant of its own
- 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
- Apr 3, 2006 · Not classified · Z-0881-06: 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 false

## Indications for use
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.

Source page: https://510kreport.com/device/K981099
Methodology: https://510kreport.com/methodology