# K061536: Microscan Dried Gram Negative Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 18, 2006 after 46 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 K013423 (2001). 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)
- K013423: Microscan Dried Gram Negative Overnight Mic/Combo Panels, Dade Microscan, Inc. (2001) Summary page 1.
- K020037: Dried Gram Negative Mic/Combo Panels, Dade Microscan, Inc. (2002) Summary page 1.

## Indications for use
The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. colt, Klebsiella spp and P. mirabilis. The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO 2 incubator, and read visually, according to the Package Insert. This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 [igml), ceftazidime (0.5-128 kig/ml) and cefotaxime (0.5-128 Itg/ml) for ESBL screening, and for the anthiicrobics ceftazidime (0.5-128 gtg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 _tg/ml), cefotaximne (0.5-128 !tg/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 jig/ml) for ESBL confirmation. The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are: Escherichiacoli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are: Escherichiacoli Klebsiella oxytoca Klebsiellapneumoniae Proteus mirabilis

Source page: https://510kreport.com/device/K061536
Methodology: https://510kreport.com/methodology