# K101425: Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Sep 10, 2010 after 113 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 K032706 (2004). 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)
- K032706: Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML, Dade Behring, Inc. (2004) Summary page 1.

## Indications for use
The MicroScan® Dried 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 16 -20 hours at 350 C ±1- I C in a non-C02 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial Doripenem at concentrations of 0.008 to 32 mcg/mI to the test panel. The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are: Acinetobacter baumanti Escherichia coli Kiebsiellapneumoniae Proteusmnirabilis Pseudomnonas aeruginosa

Source page: https://510kreport.com/device/K101425
Methodology: https://510kreport.com/methodology