# K122599: Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 3, 2012 after 37 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902336 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974325: Chiron Diagnostics Acs:180 Myoglobin, Chiron Diagnostics Corp. (1997) Summary page 2.
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2004) Summary page 2.
- K984193: Dimensions RXL Myoglobin (Myo) Calibrator, Dade Behring, Inc. (1998) Summary page 2.

## Recalls of this device
- Aug 8, 2016 · Class II · Z-2899-2016: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

## Indications for use
The ADVIA® Chemistry Myoglobin assay is intended for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. The ADVIA Chemistry Myoglobin calibrator is intended for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay

Source page: https://510kreport.com/device/K122599
Methodology: https://510kreport.com/methodology