# K981102: Stratus CS Myoglobin (Myo) Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 27, 1998 after 32 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- 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® analyzer: named in the summary without a submission number

## Most influential descendants
- K984065: Stratus (R) CS Myoglobin (Myo) Testpak (1998), 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

## Indications for use
The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.

Source page: https://510kreport.com/device/K981102
Methodology: https://510kreport.com/methodology