# K063045: Immulite 2000, Immulite 2500 Vancomycin

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 5, 2006 after 62 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- 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 K955851 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955851: Axsym Vancomycin II, Abbott Laboratories (1996) Summary page 3.

## Indications for use
IMMULITE® 2000 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic. The IMMULITE® 2500 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

Source page: https://510kreport.com/device/K063045
Methodology: https://510kreport.com/methodology