# K102699: Architect Igentamicin Reagents; Architect Igentamicin Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 1, 2011 after 193 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
Longest line of descent: 1 generation back to K935376 (1994). 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)
- K935376: Axsym Gentamicin, Abbott Mfg., Inc. (1994) Summary page 1.

## Most influential descendants
- K243500: ARCHITECT iGentamicin (2025), 0 descendants of its own

## Recalls of this device
- Apr 24, 2020 · Class II · Z-2117-2020: Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after 

## Indications for use
Reagents: 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 i System 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. Calibrators: The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.

Source page: https://510kreport.com/device/K102699
Methodology: https://510kreport.com/methodology