# K011720: Olympus AU5400 Clinical Chemistry Analyzer

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: Jun 25, 2001 after 21 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 9, 2013 · Class II · Z-0152-2014: 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
- Apr 26, 2013 · Class II · Z-1430-2013: Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated deter
- Jul 12, 2010 · Not classified · Z-0974-2012: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
- Jul 12, 2010 · Not classified · Z-0977-2012: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

## Indications for use
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

Source page: https://510kreport.com/device/K011720
Methodology: https://510kreport.com/methodology