# K131275: Microscan Dried Gram-Postive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Helathcare Diagnostics, Inc.
- Decided: Nov 8, 2013 after 189 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.
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)
- K003619: Dried Gram-Positive Mic/Combo Panels, Dade Microscan, Inc. (2001)

## 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 bacteria. 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 addition of the antimicrobial Tigecycline at concentrations of 0.12 - 8 mcg/ml to the test panel. MicroScan® Dried Gram-Positive Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Active in vitro but clinical significance unknown: Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates)

Source page: https://510kreport.com/device/K131275
Methodology: https://510kreport.com/methodology