# K172787: Access hsTnl

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 14, 2018 after 272 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: 2 generations back to K922823 (1992). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System, Beckman Coulter, Inc. (2013) Summary page 5.

## Most influential descendants
- 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
- K222881: Access hsTnI (2023), 0 descendants of its own

## Recalls of this device
- Aug 9, 2021 · Class II · Z-0032-2022: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack car

## 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 Immuoassay Systems to aid in the diagnosis of myocardial infarction (MI).

Source page: https://510kreport.com/device/K172787
Methodology: https://510kreport.com/methodology