# K992349: Vitros Immunodiagnostic Products Troponin I Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Aug 24, 1999 after 41 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973517 (1997). 1 ancestor in all.
4 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)
- K973517: Vitros Immunodiagnostic Products Range Verifiers, Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 1.

## Most influential descendants
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303 (2006), 2 descendants of its own
- 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
- K033300: Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers (2003), 0 descendants of its own

## Indications for use
Assayed for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnI). For in vitro use.

Source page: https://510kreport.com/device/K992349
Methodology: https://510kreport.com/methodology