# K935376: Axsym Gentamicin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: Jun 21, 1994 after 225 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102699: Architect Igentamicin Reagents; Architect Igentamicin Calibrators (2011), 1 descendant of its own
- K243500: ARCHITECT iGentamicin (2025), 0 descendants of its own
- K012311: Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests) (2001), 0 descendants of its own

## Recalls of this device
- Oct 26, 2007 · Not classified · Z-0930-2008: Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: - Printed Error Code

Source page: https://510kreport.com/device/K935376
Methodology: https://510kreport.com/methodology