# K042479: Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 6, 2005 after 115 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- 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 K904226 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962519: Emit 2000 Gentamicin Assay and Calibrators, Behring Diagnostics, Inc. (1996) Summary page 3.
- K042476: Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos, Ortho-Clinical Diagnostics, Inc. (2004). Cleared while this submission was under review Summary page 4.

## Recalls of this device
- Jul 19, 2005 · Not classified · Z-1460-05: Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT). For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K042479
Methodology: https://510kreport.com/methodology