# K061687: Microscan Dried Gram Negative Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 21, 2006 after 36 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 K020037 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichiacoli, Klebsiella spp. and Proteus mirabilis. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO₂ incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert. This particular submission is for the use of cefotaxime (2, 16 jig/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 jig/ml), ceftazidime (1, 8 tg/ml) and ceftazidine/clavulanic acid (0.25/4, 2/4 jig/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods. The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are: Escherichtia cobi Kiebsiella oxytoca Klebvielta pneumoniiae Proreus nirabilii The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamnase (ESBL) production in Escherichiacoli, Kiebsiella spp. and Proteus mirabilis. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO₂ incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert. This particular submission is for the use of cefotaxime (2, 16 jig/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 jig/ml), ceftazidime (1, 8 ltg/ml) and ceftazidime/clavulanic acid (0.25/4, 2/4 ltig/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods. The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are: Litcherichia co/i Kiebsiella Oxytoca Klebsielia p'ietmonice Proteus inbiisazt

Source page: https://510kreport.com/device/K061687
Methodology: https://510kreport.com/methodology