# K243500: ARCHITECT iGentamicin

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jul 9, 2025 after 239 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: 2 generations back to K935376 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102699: Architect Igentamicin Reagents; Architect Igentamicin Calibrators, Abbott Laboratories (2011) Summary page 6.

## Indications for use
The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K243500
Methodology: https://510kreport.com/methodology