# K123933: Microscan Dried Gram-Positive Mic/Combo Panels - Ceftaroline

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 14, 2013 after 84 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- 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 K003619 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003619: Dried Gram-Positive Mic/Combo Panels, Dade Microscan, Inc. (2001) Summary page 1.

## Most influential descendants
- K150039: MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (2015), 2 descendants of its own
- K250036: MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (2025), 0 descendants of its own
- K152346: MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (2015), 0 descendants of its own

## Indications for use
The MicroScane 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 bacteria. After inoculation, panels are incubated for 16 -20 hours at 35 0 C +/- 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 Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel. The gram-positive organisms which may be used for Ceftaroline susceptibility testing in this panel are: Staphylococcus aureus * methicillin-susceptible and methicillin-resistant isolates - skin isolates only * methicillin-susceptible isolates - community-acquired bacterial pneumonia isolates

Source page: https://510kreport.com/device/K123933
Methodology: https://510kreport.com/methodology