# K111394: Microscan Microstep

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 22, 2011 after 35 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: 2 generations back to K963641 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020556: Microscan Microstrep Plus Panel with Levofloxacin, Dade Microscan, Inc. (2002) Summary page 1.

## Indications for use
The MicroScan® MICroSTREP p/us® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci. After inoculation, panels are incubated for 20 -24 hours at 3500 +/- 100 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 Daptomycin at concentrations of 0.25 to 8 pg/mI to the test panel. The organisms which may be used for Daptomycin susceptibility testing in this panel are: Streptococcus pyogenes Streptoccocus age/acie Streptococcus dysglectiae su bsp. equisimilis

Source page: https://510kreport.com/device/K111394
Methodology: https://510kreport.com/methodology