# K031601: Microscan Synergies Plus Gram Negative Mic/Combo Panels with Cephalothin (0.5-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 2, 2004 after 317 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The MicroScan® rapID/S plus Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 — 18 hours at 35°C +/- 1°C, in a WalkAway® S/ or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CQO, incubator and the AST portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Cephalothin, at concentrations of 0.5 to 32 pg/ml, to the test panel. The gram-negative organisms which may be used for Cephalothin susceptibility testing in this panel are: Escherichia coli Klebsiella pneumoniae Proteus mirabilis The MicroScan® Gram rapID/$ plus Gram-Negative Panels with Cephalothin is not intended for use with: Klebsiella oxytoca Proteus penneri Enterobacter spp. Providencia spp Citrobacter freundii Serratia spp. Morganella morganii Yersinia enterolitica Proteus vulgaris

Source page: https://510kreport.com/device/K031601
Methodology: https://510kreport.com/methodology