# K010429: Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 5, 2001 after 112 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
No predicates in its family tree.
13 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345 (2002), 12 descendants of its own
- 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

## 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

Source page: https://510kreport.com/device/K010429
Methodology: https://510kreport.com/methodology