# K112412: AU5800(R) Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 23, 2011 after 123 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002982 (2000). 1 ancestor in all.
3 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)
- K002982: Olympus AU2700 Clinical Chemistry Analyzer, Olympus America, Inc. (2000) Summary page 1.

## Most influential descendants
- K161837: ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (2016), 2 descendants of its own
- K220977: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (2023), 0 descendants of its own
- K183375: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (2019), 0 descendants of its own

## Recalls of this device
- Feb 13, 2017 · Class II · Z-1704-2017: Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
- Jul 30, 2015 · Class II · Z-2310-2016: Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting i
- Sep 9, 2013 · Class II · Z-0153-2014: The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure ca
- Jun 3, 2013 · Class II · Z-1834-2013: The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the conce
- Mar 20, 2013 · Class II · Z-1167-2013: Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 syst
- Nov 28, 2012 · Class II · Z-0913-2013: Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts 
- Oct 26, 2012 · Class II · Z-1873-2013: Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.

## Indications for use
The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode. The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Potassium test system is for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

Source page: https://510kreport.com/device/K112412
Methodology: https://510kreport.com/methodology