# K962919: Vitros Immunodiagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Oct 18, 1996 after 84 days
- Product code: KHO (Fluorometer, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983133: TBIL (1998), 0 descendants of its own

## Recalls of this device
- Feb 20, 2019 · Class II · Z-1293-2019: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Feb 20, 2019 · Class II · Z-1292-2019: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Aug 24, 2011 · Not classified · Z-0923-2012: Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanie
- Aug 24, 2011 · Not classified · Z-0924-2012: Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanie
- Sep 29, 2005 · Not classified · Z-0137-06: When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased.

Source page: https://510kreport.com/device/K962919
Methodology: https://510kreport.com/methodology