# K012311: Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 20, 2001 after 28 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- 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 K935376 (1994). 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)
- K935376: Axsym Gentamicin, Abbott Mfg., Inc. (1994) Summary page 2.

## Indications for use
For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.

Source page: https://510kreport.com/device/K012311
Methodology: https://510kreport.com/methodology