# K043384: Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Feb 7, 2005 after 60 days
- Product code: LDO (Enzymatic Radiochemical Assay, Tobramycin)
- Device class: 2
- Regulation: 21 CFR 862.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984288 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003341: Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators, Syva Co., Dade Behring, Inc. (2001) 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) Summary page 3.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA). 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 TOBRA on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K043384
Methodology: https://510kreport.com/methodology