# K121790: Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 25, 2013 after 464 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922823 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053020: TNL-Ultra Assay for the Advia Centaur System, Bayer Healthcare, LLC (2005) Summary page 2.
- K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100, Beckman Coulter, Inc. (2003) Summary page 2.

## Recalls of this device
- Nov 26, 2025 · Class II · Z-1025-2026: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If thi
- Nov 26, 2025 · Class II · Z-1026-2026: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If thi
- Oct 1, 2025 · Class II · Z-0428-2026: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Pau
- Oct 1, 2025 · Class II · Z-0429-2026: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Pau
- Aug 21, 2014 · Class II · Z-2687-2014: Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassa

## Indications for use
The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction. The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction. The UniCel DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Source page: https://510kreport.com/device/K121790
Methodology: https://510kreport.com/methodology