# K983848: Abbott Axsym Myoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 16, 1998 after 17 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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® Myoglobin Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Most influential descendants
- K042924: Architect Stat Myo Immunoassay (2005), 3 descendants of its own
- K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge (2012), 1 descendant of its own
- K112161: AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge.. (2012), 1 descendant of its own
- K163462: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (2017), 0 descendants of its own

## Recalls of this device
- Jan 19, 2009 · Not classified · Z-1050-2009: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
- Apr 23, 2007 · Not classified · Z-1030-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru

## Indications for use
AxSYM® Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System. Measurements obtained by this device aid in the rapid diagnosis of heart or renal disease.

Source page: https://510kreport.com/device/K983848
Methodology: https://510kreport.com/methodology