# K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 14, 2013 after 417 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: 1 generation back to K922823 (1992). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 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.
- K922823: Access Theophylline Immunoassay Reagents, Bio-Rad Laboratories, Inc. (1992) Summary page 2.

## Most influential descendants
- K172787: Access hsTnl (2018), 4 descendants of its own
- K230648: Access hsTnI (2023), 2 descendants of its own
- K243483: Access hsTnI (2025), 0 descendants of its own
- K242870: Access hsTnI (2025), 0 descendants of its own
- K242190: Access Cortisol; DxC 500i Clinical Analyzer (2025), 0 descendants of its own

## Recalls of this device
- Nov 7, 2025 · Class II · Z-0889-2026: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like defo
- Feb 5, 2025 · Class II · Z-1386-2025: Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was tra
- Nov 18, 2024 · Class II · Z-0727-2025: Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and 
- Jan 26, 2023 · Class II · Z-1257-2023: An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/
- Oct 6, 2014 · Class II · Z-0175-2015: Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation 

## 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 Access 2 Immunoassay System 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 Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction. The Access 2 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/K121214
Methodology: https://510kreport.com/methodology