# K020692: Emit 2000 Vancomycin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 10, 2002 after 67 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 K881040 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881040: Emit Vancomycin Assay, Syva Co. (1988) Summary page 1.

## Most influential descendants
- K043386: Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and Iii (2005), 0 descendants of its own

## Indications for use
The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K020692
Methodology: https://510kreport.com/methodology