# K131546: AU Bicarbonate Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Oct 9, 2013 after 133 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K9003: Carbon Dioxide - DST. Number could not be read Summary page 1.

## Recalls of this device
- Oct 14, 2025 · Class II · Z-0997-2026: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
- Apr 5, 2023 · Class II · Z-1608-2023: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
- Apr 5, 2023 · Class II · Z-1607-2023: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
- Apr 5, 2023 · Class II · Z-1606-2023: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

## Indications for use
AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K131546
Methodology: https://510kreport.com/methodology