# K962819: Gentamicin Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Sep 13, 1996 after 56 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott AXSYM® Gentamicin assay: named in the summary without a submission number

## Most influential descendants
- K062024: Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge (2006), 0 descendants of its own

## Recalls of this device
- Apr 19, 2018 · Class II · Z-2182-2018: The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation bet
- Apr 19, 2018 · Class II · Z-2181-2018: The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation bet

## Indications for use
The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K962819
Methodology: https://510kreport.com/methodology