# K062179: Microscan Dried Gram-Positive Mic/Combo Panels with Erythromycin (0.25 - 16UG/ML)

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Aug 23, 2006 after 23 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- I°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This submission is to evaluate the performance of the antimicrobial agent Erythromycin on the MicroScan® Dried Gram-Positive MIC/Combo Panels read on MicroScan® WalkAway and autoSCAN-4 Instruments utilizing the current DMS or LabPro version <2.0 Software platforms. The Gram-Positive organisms which may be used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus

Source page: https://510kreport.com/device/K062179
Methodology: https://510kreport.com/methodology