# K984065: Stratus (R) CS Myoglobin (Myo) Testpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 14, 1998 after 28 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981102 (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)
- K981102: Stratus CS Myoglobin (Myo) 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
- Apr 3, 2006 · Not classified · Z-0878-06: 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
- Apr 3, 2006 · Not classified · Z-0884-06: 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
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/K984065
Methodology: https://510kreport.com/methodology