# K230648: Access hsTnI

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 4, 2023 after 270 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922823 (1992). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172787: Access hsTnl, Beckman Coulter, Inc. (2018) Summary page 4.

## Most influential descendants
- K243483: Access hsTnI (2025), 0 descendants of its own
- K242870: Access hsTnI (2025), 0 descendants of its own

## Recalls of this device
- 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 

## Indications for use
Access hsTnI 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 Systems to aid in the diagnosis of myocardial infarction (MI).

Source page: https://510kreport.com/device/K230648
Methodology: https://510kreport.com/methodology