# K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 27, 2002 after 116 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010429 (2001). 1 ancestor in all.
12 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010429: Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345, Beckman Coulter, Inc. (2001) Summary page 3.

## Most influential descendants
- K082699: Elecsys Troponin I and Troponin I Stat Test Systems (2009), 9 descendants of its own
- K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (2017), 8 descendants of its own
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (2019), 2 descendants of its own
- K202525: Alinity i STAT High Sensitivity Troponin-I (2022), 1 descendant of its own
- K230994: Alinity i STAT High Sensitivity Troponin-I (2023), 0 descendants of its own

## Recalls of this device
- Mar 11, 2010 · Not classified · Z-1995-2010: The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has confirmed additional reports that each of the following assays may produce lower than expect
- Feb 6, 2010 · Not classified · Z-1318-2010: The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Va
- Dec 10, 2009 · Not classified · Z-1883-2011: The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced Acc

## Indications for use
The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

Source page: https://510kreport.com/device/K021814
Methodology: https://510kreport.com/methodology