# K043386: Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 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: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881040 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020692: Emit 2000 Vancomycin Assay, Dade Behring, Inc. (2002) Summary page 3.
- K020845: Emit 2000 Vancomycin Calibrators, Dade Behring, Inc. (2002) 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.

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1833-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- Feb 21, 2017 · Class II · Z-1887-2017: Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability d
- Oct 12, 2005 · Not classified · Z-0173-06: Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC). 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 VANC on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K043386
Methodology: https://510kreport.com/methodology