# K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Dec 19, 2006 after 89 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973517 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974075: Access Troponin I Reagents on the Access Immunoassay Analyzer, Beckman Instruments, Inc. (1997) Summary page 2.
- K992349: Vitros Immunodiagnostic Products Troponin I Range Verifiers, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 2.

## Most influential descendants
- K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (2025), 0 descendants of its own
- K241165: Atellica® IM High-Sensitivity Troponin I (TnIH) (2024), 0 descendants of its own

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2357-2023: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- Jun 5, 2023 · Class II · Z-2358-2023: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

## Indications for use
VITROS® Troponin I ES Reagent Pack: For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. VITROS® Troponin I ES Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnl) in human serum and plasma (heparin and EDTA). VITROS® Troponin I ES Range Verifiers: For in vitro diagnostic use only. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).

Source page: https://510kreport.com/device/K062838
Methodology: https://510kreport.com/methodology